Ask the Expert — an educational and interactive series for lab professionals by Thermo Fisher Scientific, the world leader in serving science.
The scientific community, with expertise in discoveries, breakthrough and innovations, is being pushed to deal with challenges daily. Our best efforts always come from collaboration and sharing of information and expertise. We hear that you need to cut down your hours in the lab on analysis and get the results fast. Yes, we know that as lab professionals, you face a multitude of challenges including productivity, flexibility, sensitivity, reproducibility, ease of operation and compliance.
With this in mind, we bring together some of the leading experts we know, to hear from you and help you by sharing more to overcome your lab challenges. “Ask the Expert” is a series of 30-minute webinars and 30-minute live Q&A sessions that will address your concerns in the laboratory. Whether it is about chromatography, mass spectrometry or trace elemental analysis, this group will sound off regularly on questions about overcoming obstacles, weigh in on latest technology and even what books sit on their nightstands—and they will share responses in this virtual town square.
Analysis of impurities in pharmaceutical products: Alleviating the pain of common challenges in the laboratory
This presentation will highlight the most common challenges around the analysis of elemental impurities (and beyond) as well as useful tips and tricks for setting up the entire analytical system (hardware and software) so that full regulatory compliance is achieved effortlessly.Watch now Q&A
Questions and Answers
In the spirit of collaboration, sharing of information and expertise, these are some of the questions that were raised in the session and henceforth, responses from our Experts. If you have more questions with regard to the topic, please fill in your enquiry here.
Event: Analysis of impurities in pharmaceutical products - Alleviating the pain of common challenges in the laboratory
| Question | Answers |
|---|---|
| What should I do if I want to analyze elemental impurity, but I don't have microwave digestion as per USP requirements? How will that affect my sample and what is the alternative? | As per USP chapters 232/233, sample preparation can be carried out following any of the approaches mentioned below, depending upon the nature of the sample:
- If the sample is soluble in water, a simple dilution using acidified water can be used. - If sample is soluble in organic solvents, it can be prepared by simple dilution using that particular organic solvent as diluent. In this case, linearity standards should be prepared using the same solvent as diluent in order to match the matrix between standards and samples. The preferred organic solvents for this purpose are mostly polar solvents such as DMSO, DMF, acetonitrile, IPA etc. In case direct dissolution in organic solvent is the favored approach for sample preparation, it is important to ensure that ICP-OES/MS systems are equipped with appropriate accessories required in order to handle organic solvents effectively. - If sample is not completely soluble in water as well as organic solvents (e.g. tablets, capsules or raw materials), sample preparation has to be carried out using closed vessel microwave digestion to assure complete decomposition prior to analysis. As per USP guideline, sample must be prepared using closed vessel microwave digestion system (whenever required) as other sample preparation techniques, such as ashing, followed by dissolution in acidified water, open vessel digestion etc. can lead to the loss of volatile analytes, such as Hg, As, Cd and Pb. Evaporation will result in inaccurate determination of these analytes, affecting method accuracy. |
| If I were to choose only one of the three equipment for Pharma Testing Lab, which of the three AA, ICP and ICP-MS would you suggest and why? | In such cases, a multi-element technique like ICP-OES or ICP-MS is certainly a better choice compared to a technique like AA, which requires analysis on individual elements sequentially. Among the two remaining techniques, the choice for either ICP-OES or ICP-MS should depend on the expected workload and also whether or not the instrument should be potentially used for other tasks in R+D in the future. For laboratories tasked with mainly QA/QC analysis and i.e. supporting a production, ICP-OES is a more cost-effective solution, whereas ICP-MS should be preferred in case an increase of samples or other applications is a realistic scenario for the future. |
| Any modifications required for the existing instrument to comply with the new chapter 232? | Existing instruments can be used for the analysis of elemental impurities normally without modifications. However, there may be exceptions in certain scenarios. If for example ICP-OES is used for the screening of contaminants in effluent waters from production, whereas for USP compliance sample preparation in organic solvents is required, at least a modification of the sample introduction system is required. At the same time, it should be considered that potential carry over from one sample type to another may be a potential risk, especially for cases like the above mentioned. A dedicated instrument for impurity testing is a better choice in these cases to avoid laborious configuration changes, potential instrument downtime or QC/sample failures. The impact of such failures can exceed the investment into a dedicated instrument quickly. |
| How does the technique for sample preparation avoid or minimize evaporation of Volatile elements such as Arsenic, Selenium and Mercury?
Can we apply the same sample preparation technique for heavy metal assay in solid and liquid dosage form? |
In order to preserve volatile analytes like As, Hg in the solution during sample preparation, it is recommended by USP to use microwave digestion systems when samples are not completely soluble either in water or in organic solvents.
It is difficult to generalize sample preparation method for any of the sample type because of the vastly different formulation including API and excipients. Depending upon the chemical and physical nature of the sample, preparation for analysis has to be accomplished either by dilution, dissolution or microwave digestion. Please note that the ultimate objective of the sample preparation is to destroy the sample matrix and to obtain ideally a crystal-clear liquid solution without presence of any suspended particles, sediments or precipitate. |
| Which elements generally give false positive or false negative results? | There is no general rule or a generic answer to this question unfortunately.
False negatives most likely will result from incorrect sample preparation (such as the loss of volatile elements in an open digestion). Good examples for elements prone to artifacts in sample preparation are mercury and osmium. Both will benefit significantly from the addition of suitable reagents for stabilization. Usually, in both ICP-OES and ICP-MS, the presence of potential interferences, leading to false positive results, will always depend on the full composition of the sample and the sample preparation strategy (i.e. the acids used in the process). However, there are some elements that are suffering from specific influencing factors that can be avoided or corrected for with low or medium effort. For ICP-MS in particular, vanadium and chromium can be biased by the presence of chlorine, arsenic and selenium can suffer from false positive signals for example in the presence of rare earth elements in the sample, or, especially when direct dissolution in aqueous media is chosen for sample preparation, artificial signal enhancement through the presence of carbon. Cadmium and Mercury can be affected by polyatomic interferences from molybdenum or tungsten. To recognize the potential occurrence or presence of interferences, it is recommended to perform a full analysis of each unknown sample, including also element which are not subject to quantitative assessment. This can be accomplished through the acquisition of a full frame image (in ICP-OES) or a full mass spectrum (in ICP-MS). Both will add only a few seconds to the analysis time per sample but can provide valuable insights into troubleshooting in case results are not straightforward to interpret. To run survey scans is also a good means to recognize potential contaminations in the process. |
| Do you recommend following the guideline of sample collection for analysis? What are important factors which may contribute to the validity of the results? | There is no such guideline available for sample collection as far as elemental analysis in pharmaceutical products is concerned as per USP 232/233 chapters. Generally, one needs to be careful while collecting sample in order to fulfill general sampling requirements such as homogeneity, representative sampling of the bulk material etc.
It is also important to avoid the use of any metal spatulas or any other metal or glass apparatus while collecting a sample, as the use of such materials can potentially lead to contaminations with a potential analyte of interest. The most common challenge with elemental analysis is cross contamination of analytes from apparatus, reagents, water and from environment itself. One needs to be extremely careful and follow necessary steps in order to avoid such issues. |
| What is the procedure for sample preparation for phosphorus analysis in ICP-OES? | It depends on the form in which phosphorous is present. Phosphates are not soluble in water and are slightly soluble in acidic medium. One needs to be very careful in order to avoid cross contamination from the atmosphere and surrounding while preparing standards and samples. |
| As per chapter 233 parameters "Detectability" (spiked sample solution 1.0J and 0.8J), how can I prepare it in liquid form dosage? | In order to calculate J-value, it is required to consider the permissible daily exposure (PDE) depending upon the route of administration (oral, parenteral or inhalation) of the product, the maximum daily dose and the dilution factor used for sample preparation (in order to match the working range of the analytical instrument used).
J value (1J) = PDE /(Total Dilution x Max Daily Dose) Once the J values is determined, other levels of J value can be prepared by serial dilution of stock solution (e.g. 10J). Spiking should ideally be accomplished before the start of the sample preparation, so that influences of all steps in the process are included in the following determination of the accuracy. |
Simple to the CORE – The new Thermo Scientific Vanquish Core HPLC system
Built upon the innovative Vanquish platform, the new Vanquish Core HPLC system provides exceptional analytical precision, detector sensitivity, and operational simplicity to enable unprecedented reliability and robustness. Designed specifically for routine analysis laboratories. Addressing the benefits of our exceptional technology.Watch now Q&A
Questions and Answers
In the spirit of collaboration, sharing of information and expertise, these are some of the questions that were raised in the session and henceforth, responses from our Experts. If you have more questions with regard to the topic, please fill in your enquiry here.
Event: Simple to the CORE – The new Thermo Scientific Vanquish Core HPLC system
| Question | Answers |
|---|---|
| How can this Technology be more easy for students? | Chromeleon CDS can support academic learning through streamlined workflows using eWorkflows. This simplifies sequence setup and ensures correct methods and reports are used for each anaylsis. With Chromeleon 7.3 CDS, students can install it on their own PCs, get a 60 day temporary license, take their data on e.g. a thumb drive in CMBX format and analyse this data remotely, offline. |
| How fast does HPLC show the result when having mixture of two different molecules in the solution? How about with both having different solubility in the solvent? | The time it takes to separate two analytes depends on the nature of the compounds and the combination of mobile and stationary phase. If only simple separation is required, it is possible to complete it in less than a minute. Separations of very similar compounds might not even be completed after 30 minutes or more. |
| What happens if my sample solvent is stronger or weaker than my mobile phase? | Injecting a weaker-eluting solvent, for instance a water-rich solvent, in reversed phase HPLC typically has a positive effect. Analytes are enriched at the head of the column until the eluting takes effect. This typically leads to narrower peaks and therefore better peak resolution. With a stronger eluting sample solvent, for instance methanol for RP chromatography, early eluting peaks might show a fronting. The extent of the effect depends on the injection volume and the column volume. It can also play a role in method transfer. With Vanquish Core we published an application note that helps with how to deal with this. |
| How long will HPLC systems be supported and tests ranges extended in the era of Tandem Mass Spec? | A great thing about Vanquish Core is the flexibility of the platform. One can easily combine different types of pumps and add-ons; for instance column switching valves. Vanquish Core will therefore also be able to support tandem mass spec analyses. The software infrastructure to support this will be available in the near future. With respect to the time, Vanquish Core is technically supported with spares and wears: The product has just been launched and will remain on the market for several years. From the time the product is no longer manufactured, Thermo Fisher Scientific guarantees at least 7 years of full product support. |
| Is Vanquish core suitable for small labs? Is there a requirement of minimum samples analyzed each day to have optimum benefit from the system? Can it be controlled from desktop PC like CM7 software? |
Chromeleon 7.3 CDS is the recommended software for the Vanquish Core HPLC. It supports working locally on a single PC and also remote working via a network so the instrument can be controlled and monitored from an office along with data processing and reporting |
| How do you check for reproducibility and robustness? | The Chromeleon ICH Method Validation Extension Pack provides everything you need to perform reproducibility and robustness testing with predefined report templates to automate reporting. |
| Can you explain about UHPLC? Is it robust and reliable? | UHPLC was commercialized in 2004. Since then, we as a manufacturer have seen an initial adoption of the technology in research and development laboratories. Meanwhile, the pressure capabilities of most routine HPLC instruments have increased to at least 600 bar (8700 psi). A typical approach is to recommend 80% of the pressure capabilities of an HPLC instrument as maximum pressure for permanent use. With Vanquish Core, 700 bar therefore provides you with 480 bar (7000 psi) permanent pressure. The instrument is in fact designed to support this very well. UHPLC columns are based on the use of sub-2 µm particles. One of the issues with that is that the interstitual spaces are smaller than for conventional HPLC columns. These columns therefore require suitable filtering of solvents and samples to prevent clogging. My personal opinion is that many old HPLC applications can run faster using solid core particles of for instance 2.5 - 3.0 µm particle size, for instance in 3 mm i.d. columns. It is a great compromise for routine, providing much better performance than 5 µm particles in 4.6 mm i.d. columns and are not as likely to clog as sub-2 µm particle columns. |
| Is there a difference if I run a similar sample using the same column and same method on UHPLC as to compare to the same on HPLC? What are the differences? | Yes, there is. UHPLC columns use sub-2 µm particles that are more efficient than conventional HPLC columns, filled for instance with 5 µm particles. With UHPLC columns it is possible to achieve the same level of separation in a shorter time. A side effect is higher operating pressure, therefore the instrument must be suitable for these higher pressures. Another side effect can be that the interstitual volume between the particles of the column s smaller compared to HPLC columns. To avoid clogging, a suitable solvent and sample filtering is important or robust operation. |
| Compared to the previous HPLC model, what is new technology introduced in the Vanquish CORE system? Any improvement done on the solvent monitoring system? | The Vanquish Core webinar (available here) offered a good overview on the long list of new features of the Vanquish Core system. The solvent level monitoring system is introduced with Vanquish Core, and is compatible with the rest of the Vanquish platforms. |
| How is the performance of the Vanquish Core HPLC system comparable to that of Water;s or Shimadzu's Pinnacle series systems? | Vanquish Core is the most modern routine HPLC instrument. It offers a higher level of performance and dependability than any other HPLC instrument. Some highlights are the superior hardware design, diagnostics, solvent level monitoring, method transfer features and the flexibility of the instrument. Our testers confirmed that Vanquish Core allows them to do their job more reliable and more efficient than with previous, other vendor instruments. |
| What can be done if the Vanquish Core system encounters an error? | The instrument is designed in an intuitive way. It provides tools supporting novice users. In case of error or questions, we have a very strong team of supporters and engineers to help. |
| How to get good resolution and sensitivity for the separation using buffer in mobile phase system? | This is really about how to design a separation. I can recommend the book "Practical HPLC Method Development" from Kirkland, Snyder and Glajch that provides a great overview over all factors that play a role. |
| How many compounds can be analyzed efficiently in one run? | This very much depends on the nature of the column and the separation setup. Typical HPLC runs separate up to 10-15 compounds. Examples can be found here: https://appslab.thermofisher.com/ |
Perform Like a Pro: Fast ICP-OES Analysis with the Latest Advances
This webcast will focus on the most recent advances in Inductively coupled plasma-optical emission spectroscopy (ICP-OES), address challenges such as ability to analyze high matrix samples restricted to radial only instruments, balance between speed and sensitivity that are faced by analytical chemists and ensure that these challenges are no longer barriers to your trace elemental analysis.Watch now
Column Selection and Troubleshooting in Ion Chromatography
With so many different ion chromatography columns, it can be confusing to choose the right column. Join Christopher Pohl, Vice President, Chromatography Chemistry in the Chromatography & Mass Spectrometry Division of Thermo Fisher Scientific, as he reviews basic column options, the use of virtual column as a means of selecting a column, optimum column selection depending upon sample characteristics and some of the newest columns.Watch now
Automated online µSPE clean-up to improve efficiency, robustness and productivity in LC- and GC-MS/MS analysis of pesticide residues
The trend for multi-residue pesticide analysis is towards faster, simpler, more generic methods of extraction with minimal, if any, clean-up to facilitate higher sample throughput. This webinar will describe a new automated and optimized online miniaturized cartridge clean-up providing more effective clean-up of QuEChERS extracts to overcome the analytical challenges faced by laboratories undertaking pesticides residues analysis.Watch now
Advances in Column Technology and Universal Separation Platform for Analysis of Monoclonal Antibodies (mAbs)
Biopharmaceuticals such as monoclonal antibodies are complex and consequently the array of tools and techniques required to fully characterize them is extensive. The webinar offer comprehensive overview of the advanced column technology in biopharmaceutical characterization developed by Thermo Fisher Scientific: including size exclusion, ion-exchange, hydrophobic interaction, and reversed phase chromatography.Watch now
Concepts for Application of New Instrument and Software Features for the Transfer of EP and USP Methods in HPLC
The transfer of an analytical HPLC method between different instruments in regulated routine laboratories can be challenging. Similar difficulties can be faced when a laboratory reproduces methods from pharmacopeia monographs, typically on instruments different from those used for the monograph publication.This webcast details out how new and fully compliant technologies can deliver matching chromatograms in method transfer between different HPLC instrument
Watch now Q&A
Questions and Answers
In the spirit of collaboration, sharing of information and expertise, these are some of the questions that were raised in the session and henceforth, responses from our Experts. If you have more questions with regard to the topic, please fill in your enquiry here.
Event: Concepts for Application of New Instrument and Software Features for the Transfer of EP and USP Methods in HPLC
| Question | Answers |
|---|---|
| What would be the main focus if we have the HPLC method and would want to apply in UPLC instrument? | If you want to apply an existing method running on a new UHPLC (identical to UPLC, which is a Waters Coporation trademark) instrument this means normnally you want to accelerate you method. This means you change the column format (often 4.6 mm with 5 µm particale) to lower inner diamter columns (2.1 mm) and sub 2 µm column particle size. In such case, the gradient table, injection volume and flow rate need to be changed. To accomplish this there are great online tools avaialble will do the match for you. In Chromeleon CDS you can calculate these change directly from your existing method and apply this new method to you instrument. However, if you would like to use the identical column (4.6 mm ID) you check two main aspects. Becasue the dispersion of a modern UHPLC instrument is way less than stnadrd HPLC instrument you need to take care of any solvent mismatches that might occure when for instance injecting high organic samples (stronger elution strength than eluent). In addition, due to the narrow tubing care should be taken to only work with really clean and completely dissolved ssamples oion order to avoid clogging of the tubing. |
| How to decrease the sample concentration and volume for analysis if we have small amount of prepared samples? |
There are multiple ways how to reduce the amount of sample needed for the analysis with a liquid chromatograph. 1. Reduce simply the injection volume while simultaeously using high recovery vials. Using the most sensitive UV detectors (e.g. Light pipe technology) or changing to an alternative detection technology (Fluorescence, Charged Aerosol, mass detection) can help to increase the sensitivty. Concrete guidelines would depend analyte physical properties. Today´s HPLC amnd UHPLC instrument can inject volumes as low as 1 µL or even below reproducible. 2. Lower injection volumes are generally needed when going from standard bore 4.6 mm columns to smaller ID columns such as 2.1 mm, 1mm or even smaller ID columns. Within the portfolio of Thermo Scientific LC instrument we have instruments for all of these applications (use Chromeleon or online calculator) |
| The common LC Method Transfer Calculator only able to convert between column type, method condition such as flow and gradient table of mobile phase. I'm having trouble to transfer the existing method to other size column which the method come with FLD detection programme with a set of excitation/emission wavelengths between time (eg ISO 15753-2016 method). | To develop the most sensitive FLD detection method our fluorescence detectors enable a 3D flied acquisition to determine optimal excitation and emmission wavelength. Detailed guidelines can be found in this method development handbook . |
| What is the challenge to get good accuracy during the method transfer involving instruments from different vendors or with different configurations? | Vanquish HPLC and UHPLC systems are built to optimze the analytical precision. In order to match the previous analysis on a new instrument e.g. A Vanquish Core instrument, we implemented a couple of unique features to make that transfer as easy as possible. 1. Tunable Gradient Delay Volume to adopt the GDV of the previous instrument 2. Variable column thermostatting options 3. Custom injection programs to deal with high organic strength samples |
| Can HPLC can be applied for the invention of new drugs? | HPLC is a tool that is extremly widely used in pharmaceutical research. This technique is needed to qualitatively and quantitatively characterize samples. This includes drug candidate analysis with often an LC-MS instrument as well as to control the quality during pharmaceutical production |
| challenges while analytical method developed on UPLC and transferring on normal HPLC system. | Transferring a method that was originally developed on an UHPLC instrument and now needs to be transferred to a standard HPLC instrument can be challenging but depends on the used column format. For instance if the method developed on the UHPLC is using a HPLC like 4.6 mm column, there will be little problems to transfer the method. However, if the method is based for instance on a 2.1 mm column with 1.9 µm particle the problems might be more visible. The most severe challenges will be the overall system pressure (depending on column length) as well as the system dispersion. For the post column dispersion especially the flow cell volume needs attention. Also the injection volumes are often small for UHPLC analysis. It needs to be checked if the HPLC instrument is able to deal with this. The best HPLC instrument on the market to also run UHPLC kind of applications is the Vanquish Core instrument. This instrument as pressure limit of 700 bars, post column dispersion characteristics can be easily changes by using fingertight Viper fitting and low volume flow cells and the autosampler is able to inject typical UHPLC sample volumes. |
| Method and condition replication to achieve robustness in another laboratory for method validation of a newly developed analysis method. | The Chromeleon ICH Method Validation pack provides everything you need to perform reprodcibility and rebostness testing with predifined and automoated reporting during your method development process. In addition, dedicated software tools, for instance AutoRobust from Chromsword, are tested to work with Thermo Scientific LC instruments and accelerate the method development process |
| How does sample pre mixing with mobile phase help improve the peak shape? | Sample premixing aims to reduce the elution power of the sample which is a common cause for poor peak shapes, besides any column effects. With a lower elution power the sample can be focused on the column head. With this dilution approach the analyte concentration will be decreased and thus need a higher injection volume. A best first appropach would be to keep the mass on column of the analyte constant. Care most be taken that the analytes are still soluble in the weaker mobile phase and do not preticipate |
| What's the most remarkable thing about this technology? | Vanquish Core has several features to facilitate the transfer of methods, so bringing an existing method to a new instrument such as the Vanquish Core. This is: - a freely tunable gradient delay volume to match the gradient delay volume of other common HPLC instruments - multiple column thermostatting options to mimic other vendor thermostatting concepts - Custom Inject Programs for in needle sample dilution prior to injection |
| In the case of analysis of additives in emulsion and aqueous samples, there are difficulties such as insolubility and precipitation during pretreatment. Please advise any helpful tips or measurement considerations. | For liquid chromatography it is mandatory to have the analyte dissolved. Thermodynamic and kinetic considerations need to be taken. Common advices such as ultrosonic bath, heating etc need to be evaluated in a case by case study |
| How effective is method transfer for herbal products? | The challenge for herbal products is the complexity of the sample and chromatogram. Vanquish Core is the best instrument for such transfer as it comes with a unique feature set to make the method transfer as easy as possible |
| How do we identify the method used in sample running? | Chromeleon CDS provides a sequence table with all samples used and the respective instrument methods. Chromeleon audit trail features will log all this data so that any time the instrument details for a particular sample can be reviewed. |
| 1. Which items should/must be included in the comparasion protocol/report? (linearity, solution stability, Robutness, specificity..and so on.) 2. (continuted), how to set the criteria? 3. Can Thermo help to study the comparsion report and validate? |
For detailed answers we would need to get more details. However, in general Thermo Scietific HPLC experts are happy to help with the transfer of analytical methods to Thermo Scientific HPLC systems. Contact our HPLC experts now. |
| How to overcome the issue of sample denaturation due to less stable in unfavorable environment in HPLC? | The common causes that accelerate sample degradation are temperature, light induced oxidation or oxidation caused by air oxygen. To remove the temperature effect all our autosampler can be ordered with a very effective cooling option. Minimizing the light effect can be done by turning of the light in the autosampler or using brown glass vials. For oxidation caused by oxygen is probably the hardest to fix. Filling the vials under an nitrogen atmosphere might help here. Quality of vials and closures are also something to consider. Thermo Scientific offers a broad range of excellent vials, well plates and closures. |
| How to minimize the deviations in the chromatograms? Are there usefull ways to make the chromatogram always consistent? | There are three considerations I would list:
1. Differences in gradient delay volume. Here Vanquish Core is the only instrument available that can physically change the gradient delay volume seemlessly on a microliter scale 2. Differences in pre or post column dispersion. For pre-column dispersion Vanquish LC systems offer Customer Injection Programs to to for instance dilute high orgnic samples. For post column dispersion, the biggest influence comes from the flow cell. Here we provide different flow cell volumes 3. Thermostatting. This is the mode of thermostatting but also if the eluent is pre-heated or not. Vanquish Core offer multiple heating modes and pre-heating option to mimic all of these |
| What are the top three considerations when transferring a method between HPLCs of different manufactures? | There are three considerations I would list:
1. Differences in gradient delay volume. Here Vanquish Core is the only instrument available that can physically change the gradient delay volume seemlessly on a microliter scale 2. Differences in pre or post column dispersion. For pre-column dispersion Vanquish LC systems offer Customer Injection Programs to to for instance dilute high orgnic samples. For post column dispersion, the biggest influence comes from the flow cell. Here we provide different flow cell volumes 3. Thermostatting. This is the mode of thermostatting but also if the eluent is pre-heated or not. Vanquish Core offer multiple heating modes and pre-heating option to mimic all of these |
| For EP/USP method transfer, what are some verification parameters that we should be aware of? | In general there are no regulatory guidelines on which parameter need to be measured. In any case, it is important to work out beforehand a clear method trasnfer plan with pre-defined acceptance criteria such as area precision, LOD, linearity, robustness, specificty etc. Also statistical analysis are important and different approaches exists. The Chromeleon ICH Method Validation pack provides everything you need to perform reprodcibility and rebustness testing with predifined and automoated reporting during your method development process. |
| What are some of the basic instrument care that have to be taken into consideration when we do method transfer? | When doing a method transfer with Vanquish Core no special care has to be taken for instrument. The Method transfer kit is an optional part for the Vanquish Core HPLC system. This part will help to have a broader range of gradient delay volume for mimicing other instruments. Thus we recommend this optional part for the purpose of method transfer. |
| What are some ways for method and condition replication to achieve robustness in another laboratory for method validation of a newly developed analysis method? | We recommend thorough robustness testing during the method velopment process. Typical parameters to check are influence of varifying pH value, different column lots etc |
| What are regulatory guidelines over method transfers between various vendor instruments? What changes are allowed in hardware/software parameters? | In the method transfer for HPLC section of general chapter <621> in the USP41, modifications of the method are tolerated within limits. For the gradient delay volume (named dwell volume in the USP) it is stated that, if adjustments are necessary, change in column packing (maintaining the same chemistry), the duration of an initial isocratic hold (when prescribed), and/or gradient delay volume adjustments are allowed.” This means that changes of the gradient delay volume as done by the method transfer kit are explicitly approved as a suitable tool for method transfer. For the approach with Vanquish Core the gradient delay volume can be altered with any need for re-qualification of the instrument as now part are exchanged. The settings to change the gradient delay volume are tracked in the instrument audit trail. |
| How to optimize the auto/manual integration during the method transfer of one brand of HPLC to Thermo UHPLC? | Chromatography Data systems has can integrate peaks in multiple ways. The unique SmartPeaks of Chromeleon CDS feature would even show a comparison of different integration procedures. This way difference comming for instance from a valley to valley or drop perpendiculum integration can be directly compared. |
Updating your Peptide Mapping and Glycan analysis for Therapeutic proteins
Peptide mapping is a fundamental workflow that is required to ensure that the bio-therapeutics structural integrity is maintained at all stages of the drug development pipeline. This is required for the maintenance of drug efficacy and patient safety. This webcast details how new technologies can deliver peptide mapping.Watch now
Isotope Fingerprints for Environmental Investigations
Natural and synthetic materials have a fingerprint, a unique chemical signature that allows them to be identified and differentiated from one another. Consequently, we are able to interrogate samples, chemically, to determine where they came from, allowing measures to be developed and executed to reduce and remove environmental pollution.In this presentation we explain how stable isotope fingerprints of carbon, nitrogen, sulphur, oxygen and hydrogen are used to identify the origin of air, soil and water pollution.
Watch now
Looking for the Right Technique for Your Trace Elemental Analysis?
This webcast series will provide you with the knowledge needed to choose the right tool for your elemental analysis, including atomic absorption (AA), inductively coupled plasma-optical emission spectroscopy (ICP-OES) and ICP-mass spectrometry (ICP-MS).Watch now
Rapid and Reliable Environmental Wet Chemical Analysis
This webinar will provide an overview of automated wet chemical analysis methods for drinking and waste water, with several application examples of how the environmental water analysis could be consolidated by an automated discrete analyser.Watch now Q&A
Questions and Answers
In the spirit of collaboration, sharing of information and expertise, these are some of the questions that were raised in the session and henceforth, responses from our Experts. If you have more questions with regard to the topic, please fill in your enquiry here.
Event: Rapid and Reliable Environmental Wet Chemical Analysis
| Question | Answers |
|---|---|
| How is the sensitivity of chemical measurement in mineral water production affected if it is contaminated with high amounts of several high organic chemical compounds? | Photometric based discrete analyzers use a highly selective enzymatic or colorimetric reagents that are not affected by the organics. High organic loaded samples that are dark colored will influence the turbidity-based measurements. If the contamination is too high, it is recommended to pass the sample through the sample cleanup cartridge before measurement. pH and Conductivity cell may get fouled over a period of time and hence a time to time cleaning and activation is necessary. |
| Is there any rapid technique for detection of heavy metals in drinking water available? | Depends on the heavy metal and the concentration, the Gallery platform can determine hexavalent chromium, total iron, copper, zinc and few other metals by photometric method. These methods are rapid and reliable to a very low concentration and fulfills regulatory method requirements. If you are looking for spectrum of metals in low concentration, then Inductively coupled plasma could be a good choice. If speciation is critical then a hyphenated technique like Ion chromatography coupled with CP is a good choice. |
| Do you have solutions of auto-sampling for gallery and gallery plus? | Both Gallery and Gallery plus has sample and reagent compartment. Sample capacity differs by model. Gallery can accommodate 90 samples and Gallery plus can accommodate 108 samples. |
| Does NSF related regulatory testing requirement(s) as applicable to drinking water are satisfied for measurement accuracy using Thermo Scientific discrete analyzer / Thermo Scientific Dionex ion chromatograph? | The National Science Foundation (NSF) follows American National Standards Institute (ANSI) development process. The United States Environmental Protection Agencies (USEPA) Safe Drinking Water Act (SDWA) and the Clean Water Act (CWA) are the two important environmental laws governing water regulations. Clean Water Act Methods Update Rule for the Analysis of Effluent 40 CFR part 136 and many of the regulatory bodies, such as the ASTM, ISO, DIN recommends wet chemical methods waste water analysis. Both Thermo Scientific Gallery Discrete analyzer and Dionex Ion chromatograph fulfills several US EPA methods. Further resource can be referred here. |
| For sulphate analysis after addition of Barium Chloride, the mixture needs to be homogenized for 3-5 mins as Barium Sulphate tends to precipitate and settle at the bottom of the cuvette therefore affecting the absorbance. So how this homogenization is carried out within your analyzer? | Sulphate ion is precipitated in a strongly acid medium with Barium Chloride. The resulting turbidity is measured photometrically at 405 nm and compared with appropriate calibration standard solutions. Gallery systems has a dedicated mixture, which mixes and homogenizes samples and reagents. Further reading on Discrete Analyzer Systems. |
Online Learning
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TraceFinder 와 Vet Drugs Kit을 이용한 잔류동물용의약품 분석의 효율적인 워크플로우 및 전처리 (QuEChERS) 방법 소개
이 웨비나에서는 잔류동물용의약품 분석을 위한 전처리방법 (QuEChERS )부터 기기분석 및 데이터 정리까지의 전반적인 워크플로우를 소개할 예정입니다.Watch now
超微量多重元素分析利器 - 精準定量/定性質譜技術
ICP-MS及HR-ICP-MS為最強而有力的元素分析技術，優異的干擾消除技術，靈敏度高、分析快、基質干擾少，特別適用於特用化學、材料科學和工業產品分析實驗室，即使沒有樣品前處理也可進行超靈敏且可靠的微量等級多重元素分析。Watch now
일상적인 분석에서의 ICPMSMS의 활용
써모 피셔 사이언티픽 코리아에서는 ICP-MSMS의 기본적인 원리와 ICP-MSMS를 활용한 식품, 환경 분야의 응용을 소개하는 웨비나를 진행합니다. R&D/QA/QC에서 ICP-MS를 사용하시거나 ICP-MS 분석에 관심이 있으신 분들의 많은 참여 부탁 드립니다.Watch now
Analysis of impurities in pharmaceutical products: Alleviating the pain of common challenges in the laboratory
This presentation will highlight the most common challenges around the analysis of elemental impurities (and beyond) as well as useful tips and tricks for setting up the entire analytical system (hardware and software) so that full regulatory compliance is achieved effortlessly.Watch now
최신 이온 크로마토그래피 질량분석법을 이용한 다양한 응용 소개 (HAAs, Polar pesticides, unknown impurity ID)
본 웨비나에서는 이온크로마토그래피 최신 분석법인 IC-MSMS를 활용한 수질 샘플내 Halo Acetic Acids, 식품내 극성 농약의 효율적인 분석법 및 IC-HRMS를 이용한 샘플내 미지 이온성 불순물의 정성 분석 솔루션을 소개해 드리고자 합니다.Watch now
Analyzing the Volatilome via Secondary Electro-Spray Ionization (SESI): Technical Development and its Application to Breath and Microbial VOCs
In this webinar, the technical development of Secondary Electro-Spray Ionization (SESI) mass spectrometry and its use in real-time breath analysis will be discussed.Watch now
An automated workflow solution for the determination of MCPDe and GE
Various methodologies exist to measure bound and residual monochloropropanediol- (MCPD) and glycidyl-esters (GE) in oils at trace and ultra-trace levels. Each solution is characterized by its own particularities, giving the end-user a lot of flexibility in method choice and preference. In this webinar, a method excellently suited for productive labs will be discussed.Watch now
Enhancing Breath Biopsy Through TD-GC-Orbitrap Mass Spectrometry
This presentation will describe how integrating Orbitrap mass spectrometers into the Breath Biopsy platform has allowed us to address some of the widely accepted challenges associated with breath analysis. Breath Biopsy is a broad ranging tool that can be applied to identify and investigate biomarkers with relevance to early detection and precision medicine across a wide range of diseases including asthma, liver disease and cancers.Watch now
Rapid and Reliable Environmental Wet Chemical Analysis
This webinar will provide an overview of automated wet chemical analysis methods for drinking and waste water, with several application examples of how the environmental water analysis could be consolidated by an automated discrete analyser.Watch now
Looking for the Right Technique for Your Trace Elemental Analysis?
This webcast series will provide you with the knowledge needed to choose the right tool for your elemental analysis, including atomic absorption (AA), inductively coupled plasma-optical emission spectroscopy (ICP-OES) and ICP-mass spectrometry (ICP-MS).Watch now
Updating your Peptide Mapping and Glycan analysis for Therapeutic proteins
Peptide mapping is a fundamental workflow that is required to ensure that the bio-therapeutics structural integrity is maintained at all stages of the drug development pipeline. This is required for the maintenance of drug efficacy and patient safety. This webcast details how new technologies can deliver peptide mapping.Watch now
Isotope Fingerprints for Environmental Investigations
Natural and synthetic materials have a fingerprint, a unique chemical signature that allows them to be identified and differentiated from one another. Consequently, we are able to interrogate samples, chemically, to determine where they came from, allowing measures to be developed and executed to reduce and remove environmental pollution.In this presentation we explain how stable isotope fingerprints of carbon, nitrogen, sulphur, oxygen and hydrogen are used to identify the origin of air, soil and water pollution.
Watch now
Concepts for Application of New Instrument and Software Features for the Transfer of EP and USP Methods in HPLC
The transfer of an analytical HPLC method between different instruments in regulated routine laboratories can be challenging. Similar difficulties can be faced when a laboratory reproduces methods from pharmacopeia monographs, typically on instruments different from those used for the monograph publication.This webcast details out how new and fully compliant technologies can deliver matching chromatograms in method transfer between different HPLC instrument
Watch now
극성물질 분석을 위한 HPLC column selection
HPLC 분석을 위한 효과적인 분석 방법과 극성 물질 분석을 위한 column selection 소개.Watch now
Charged aerosol detection - factors affecting uniform analyte response for analysis impurity
최근 UV에서 검출되지 않는 불순물 분석을 위해 CAD (Charged aerosol Detector) 검출기의 활용이 늘어나고 있습니다. 불순물 분석 시 CAD는 구조와 상관없이 동일한 농도에 대해 uniform response를 얻을 수 있게 되어 불순물 정량에 활용될 수 있습니다. 이에 웨비나를 통해 최근 CAD 검출기를 이용한 제약분야의 응용과 uniform response에 영향을 끼치는 factor 들을 소개하고자 합니다.Watch now
Column Selection and Troubleshooting in Ion Chromatography
With so many different ion chromatography columns, it can be confusing to choose the right column. Join Christopher Pohl, Vice President, Chromatography Chemistry in the Chromatography & Mass Spectrometry Division of Thermo Fisher Scientific, as he reviews basic column options, the use of virtual column as a means of selecting a column, optimum column selection depending upon sample characteristics and some of the newest columns.Watch now
Automated online µSPE clean-up to improve efficiency, robustness and productivity in LC- and GC-MS/MS analysis of pesticide residues
The trend for multi-residue pesticide analysis is towards faster, simpler, more generic methods of extraction with minimal, if any, clean-up to facilitate higher sample throughput. This webinar will describe a new automated and optimized online miniaturized cartridge clean-up providing more effective clean-up of QuEChERS extracts to overcome the analytical challenges faced by laboratories undertaking pesticides residues analysis.Watch now
Food & Beverage Fraud Identification by IRMS
Food & beverage products have a fingerprint, a unique chemical signature. To visualize this fingerprint, Isotope Ratio Mass Spectrometry can be used.Watch now
同位素比值質譜儀在食品安全的應用
同位素分辨技術是國際上用於辨別食品真偽、追溯食品來源和實施產地履歷證明最具代表性的方法。賽默飛世爾科技高分辨同位素比值質譜儀具有卓越的準確度、靈敏度和穩定性，可廣泛應用於食品中蜂蜜摻假、果汁飲料摻水、農產品產地辨別、真假有機蔬果及葡萄酒溯源等鑑別檢測。本次網路研討會將介紹賽默飛世爾科技的同位素比值質譜儀及應用實例。Watch now
Rapid Photometric Detection for Food & Beverage Applications
Our DIA Specialist also discusses how these systems are an efficient alternative to traditional flow analyzers and how the unique low volume cuvette design produces cost savings in reagents and waste.Watch now
Different Sample Preparation Approaches for Food Safety Applications
Join us for a webinar to learn about modern sample preparation approaches to handle simple as well as difficult/ complex matrices in food and beverage samples with a simplified approach by utilizing advanced analytical toolsWatch now
Rapid Photometric Detection for Environmental Applications
Our DIA Specialist will also discuss how this technique is an efficient alternative to traditional flow analyzers and how the unique low volume cuvette design produces cost savings in reagents and waste.Watch now
Fast, Robust and Sensitive Analysis of Haloacetic Acids (HAAs) using IC-MS/MS
In this on-demand webinar, the presenters will share a new HAA application using innovations in ion chromatography coupled to triple quadrupole mass spectrometry and will detail the flexibility and time-savings of an optimized IC-MS setup together with its ability to offer sensitive, robust & reproducible results.Watch now
Introduction to Orbitrap Exploris 480 MS – New Platform, New Technology, Novel Capabilities
Attend this on-demand webinar to learn about proteome profiling with next generation FAIMS ion mobility technology, quantitative protein analysis and protein characterization for translational research.Watch now
Proteomic Music from Biological Noise
Dr. Pierre Thibault presented a simple, new step to their existing workflow with the addition of a novel gas phase ion fractionation device to increase proteome coverage and confidence in global proteome profiling. This study will highlight the advantages of the Thermo Scientific FAIMS Pro device in quantitative proteomics using SILAC and TMT labelling to improve the accuracy, precision, and comprehensiveness of quantitative measurements.Watch now
How to Maximize Label-Free Quantitation (LFQ) on a Tribrid Mass Spectrometer
This webinar will present the top 5 features associated with the Orbitrap Tribrid MS and demonstrate the importance of high resolution, stable mass measurement accuracy, and the introduction of the FAIMS Pro interface for balancing increased proteome coverage, maintaining relative quantitation, and maximizing throughput.Watch now
Escape the Metabolomics Identity Crisis with Intelligence Driven Mass Spectrometry
High-resolution accurate-mass spectrometry delivers informative analytical measurements providing biological insight. Yet, converting mass spectra into confidently annotated compounds is a difficult process due to the complexity of small molecules hindering confident biological interpretation. In this webinar, you’ll be introduced to new workflow strategies for data acquisition and analysis that have been developed for metabolomics applications.Watch now
Instant Answer: All the Data in Half the Time Using a Real-time Database Search for Isobaric Labeling Studies
This webinar presents strategies that combine next generation technologies in multiplexing chemistry, hardware and software for increased quantitative performance and throughput efficiency on Thermo Scientific Orbitrap Eclipse Tribrid mass spectrometer.Watch now
Mass Spectrometry in Proteomics
Join thought leaders and peers at the proteomicsNOW virtual conference to learn about the latest advances in proteomics, share best practices, and explore new technologies and techniques designed to help improve your research results.This event highlights recent developments in proteomics through live webinars, lightning talks, poster sessions, and panel discussions. Since we know how hard it is to set aside long periods of time to watch groundbreaking scientific talks, the event is available on demand as well.
Watch now
GLP施設におけるLC-MSMSでのDI対応
GLP施設で利用されている機器については，スタンドアローン仕様で利用されているものが多く，電子データを生データとして使用されているLC-MS/MSを例としデータインティグリティ確保のための課題や，課題解決のためのChromeleon クロマトグラフィーデータシステムを利用した運用管理方法を紹介する 。Watch now
Ultrahigh Performance for Resolving Proteoforms in Targeted and Discovery Modes
Laboratories who are looking to obtain rich information from proteoforms will benefit from this on-demand webinar about high quality datasets generated from the Thermo Scientific Orbitrap Eclipse Tribrid MS platform. The presented data will cover both denatured and native modes for the analysis of whole proteoforms and their complexes.Watch now
One Cell at a Time: Single Cell Proteomics Becomes a Reality
In this webinar, Dr. Ryan Kelly will describe: nanoPOTS, a new sample processing platform to maximize sample recovery; miniaturization of LC separations; and latest-generation of MS instrumentation to provide the required sensitivity and throughput for effective analysis of such trace samples.Watch now
Achieve High Throughput LC-MS Screening while Maintaining Protein Depth and Quantitative Accuracy using an Intelligence-Driven MS and Differential Ion Mobility
In this on-demand webinar, learn about how the combination of the Thermo Scientific Orbitrap Exploris 480 mass spectrometer with the FAIMS Pro interface significantly increased proteome coverage when using single VCs and short LC gradients.Watch now
Fast, reproducible biopharmaceutical charge variant profiling
In this webinar, learn about the newest addition in our comprehensive portfolio of products for bio separations.Watch now
The Sweet Revolution in Glycan and Antibody Separations
We discuss the difficulties of characterize monoclonal antibodies and other similar biotherapeutics and also the current technologies used to maximize glycan separation capabilities and structural elucidation.Watch now
Innovation and profitability in routine HPLC - Why change?
실험실의 생산성 증대와 사용자 편의의 장비 운영요구와 더불어 수익성과 관련된 장비의 Return on investment 및 Total Cost of Ownership 향상이 중요시되고 있습니다. 웨비나를 통해 일상적인 실험실 분석 업무를 위해 특별히 디자인된 Vanquish Core HPLC 시스템을 확인해 보십시오.Watch now
Understanding the Diversity in HPLC Chromatography Chemistries
In this on-demand webinar, learn about the best chemistries for sample types, and understand the benefits unique selectivity offers to improve resolution in your sample matrices, and decode different phase options available, facilitating efficient method development and eliminating the guess work.Watch now
Taking Charged Variant Analysis of Therapeutic Proteins to the Next Level
Join scientific experts from NIBRT in Dublin, Ireland and Thermo Fisher Scientific for the latest analytical advances for intact protein characterization.Watch now
How to Approach Preparative LC for Compound Purification in the Research and Development Laboratory
In this webcast, learn about the wide variety of phases, hardware, and method development tools available to help you chose the most appropriate preparative HPLC column to maximize your performance.Watch now
Prevent Unwanted Analyte Suppression – Basics of Optimizing Buffer Usage for Ionic Small Molecules and Metabolite Quantitation
Buffers are incredible if they are made and used properly. This presentation will discuss how to optimize your buffers and as a result, your chromatography.Watch now
Retention of Polar Substances using Thermo Scientific HILIC and Hypercarb Columns
Polar analytes are complex. Let us teach you about Hypercarb columns, which revolutionized chromatography of polar analytes, and let’s also talk about column chemistries that could “charge” your workflow.Watch now
Tips and Tricks for HPLC to UHPLC Method Transfer
This educational webinar will emphasize the benefits of UHPLC to routine quality testing and provide you with takeaway tips on how to effectively understand method transfer in your lab.Watch now
EASY-Spray Nano LC Column Optimization – Troubleshooting Tips & Red Flags
We’ve learned a lot about troubleshooting EASY-Spray columns and wanted to share some tips with you. Join us to learn how you can optimize your EASY-Spray workflow and signs to watch for that might indicate a problem.Watch now
HPLC Column Troubleshooting Part 2
Column care can directly impact the quality of your chromatography. Learn how to properly care for your columns and how to troubleshoot if things “go astray.” Join us for HPLC column troubleshooting part 2. Your columns will thank you!Watch now
HPLC Column Selectivity Made Easy
This presentation will help simplify how to choose the correct phase, particle size, and column dimensions, as well as explain how these choices impact your analytical and workflow needs. We will highlight how varying phases might affect your analysis.Watch now
Organic Impurity Analysis Workflows
Strategies are shown to improve productivity, reduce cost per sample and gain deeper insights for organic impurity analysis using novel UHPLC and detector technology. How to achieve confirmation, identification and quantification simultaneously with a multi-detector approach.Watch now
HPLC Column Troubleshooting Part 1
Ghost peaks can be scary, shifting peaks can be troubling, and broad peaks can be painful. Let’s talk about some common problems chromatographers face and steps to troubleshoot what’s REALLY going on with your analysis. Join us for the first part of chromatography troubleshooting and learn how to sharpen your skills and your peak shape!Watch now
Benefits of Having an Up-to-Date Chromatography Data System at Takeda Pharmaceutical Company
This webinar will present the initial selection of Chromeleon CDS as a single CDS solution at Takeda, the experiences and lessons learned during the upgrade process and the benefits that Chromeleon 7 CDS brought to the laboratory.Watch now
Broughton Laboratories Case Studies on Pharmaceutical Impurities
In this webinar, Broughton Laboratories presents their work in the area of pharmaceutical impurities focusing on method development and validation of related substances, stability studies and impurity profiling and the investigation of unknown impurities.Watch now
Inorganic Impurity Analysis Workflows
We discuss novel and existing inorganic impurities and how ICP-MS can being utilized and optimized to obtain ultimate sensitivity and rapid detection and quantitiation of such impurities. Also how automatic method development can improve productivity.Watch now
Overview of Pharmaceutical Impurities and Reference Standards
Dr. Christian Zeine presents an overview of the topic of pharmaceutical impurities including what constitutes an impurity, the various types of impurities, the regulatory guidelines and detection limits and the important points to consider during impurity testing. In addition, briefly introducing why to use reference standards and the main points to consider during their use.Watch now
Orbitrap GC-MS - Unknowns discovery workflows for the characterization of e-cigarette liquids
This webinar will share how the Thermo Scientific™ Exactive™ GC Orbitrap™ GC-MS mass spectrometer can confidently characterize the chemical content of electronic cigarette liquids.Watch now
New Analytical Workflow for the Analysis of Anionic Pesticides
This webinar focuses on the extensive optimization and performance of a new validated ion-chromatography triple quadrupole mass spectrometry based workflow for the robust, sensitive and reliable determination of a group of polar anionic pesticides and metabolites at low µg/kg levels, without the need for derivatization, and all in a single analysis.Watch now
Multi-class Veterinary Drug Quantitation with a Comprehensive Workflow
This presentation describes the development and implementation of a comprehensive multi-class veterinary drug method based on LC-MS/MS using a generic QuEChERS sample preparation. The method was validated in bovine muscle, salmon fillet, and milk to demonstrate applicability to a wide range of matrices.Watch now
Multi-Class Pesticide Quantitation with a Comprehensive Workflow
This presentation describes the development and implementation of a comprehensive multi-class pesticides method based on LC-MS/MS using a generic QuEChERS sample preparation. The method was validated in wine and olive oil to demonstrate applicability to several matrices. The method detection limits obtained were compliant with EU SANTE/11813/2017 guidelines.Watch now
Fausto Pigozzo Director of Workflow Development Thermo Fisher Scientific
Dioxin Analysis with Triple Quadrupole GC-MS/MS: How to Simplify Complexity While Ensuring Compliance with the Latest EU Regulations
This webcast illustrates the development and capability of a Dioxin Analyzer using Advanced Electron Ionization (AEI) for ultra-high sensitivity Dioxin Analysis with Triple Quadrupole GC-MS/MS. Learn how to simplify complexity while ensuring compliance with the latest EU regulations.Watch now
Richard Jack, Ph.D. Senior Director of Vertical Marketing Thermo Fisher Scientific
Understand Product Quality Attributes of Biotherapeutics through a Multi-Attribute Method (MAM) Lab-of-the-Future
Watch this webinar to learn how MS-based MAM provides simultaneous detection, identification, quantitation and quality control (monitoring) of PQAs. The webinar covers how a dedicated team at Pfizer developed a multi-site “Lab-of-the-Future” for streamlined MAM analyses.Watch now
Simple to the CORE – The new Thermo Scientific Vanquish Core HPLC system
Built upon the innovative Vanquish platform, the new Vanquish Core HPLC system provides exceptional analytical precision, detector sensitivity, and operational simplicity to enable unprecedented reliability and robustness. Designed specifically for routine analysis laboratories. Addressing the benefits of our exceptional technology.Watch now
High throughput identification of novel tomato flavonoids by a structure-based profiling and annotation Workflow
In this webinar we will discuss a structure-based profiling and annotation workflow used to investigate the flavonoid composition of peels and isolated cuticles in tomato fruit. Specifically, we will compare flavonoid profiles in wild type fruit with those of CRISPR-Cas9 genome edited lines in which the expression of three putative flavonoid transporters were eliminated.Watch now
Latest mass spectrometry-based trends for identifying and quantifying unknown PFAS compounds
In this webinar, Drs. Lee Ferguson and Abigail Joyce from Duke University discuss a Thermo Scientific Orbitrap Mass Spectrometer-based method used to demystify unknown PFAS compounds in drinking water.Watch now
Improving Proteome Coverage and Peptide Identification Rates in Short LC Gradients
In this webcast, the speaker will present first impressions of the Thermo Scientific Orbitrap Exploris 480 mass spectrometer equipped with a Thermo Scientific FAIMS Pro interface for shotgun proteomics. The performance of the new instrument is evaluated in data-dependent acquisition (DDA) and data-independent acquisition (DIA)* modes with fast scanning HCD methods in combination with front-end Field Asymmetric Ion Mobility Spectrometry (FAIMS).Watch now
Ion Chromatography Tips and Tricks
In this webinar you will hear directly from an IC Specialist who will share vital tips and tricks to ensure you are getting the most from your Ion Chromatography instrument.Watch now
Ion Chromatography Column Selection
Have you ever wondered why there are so many different types of ion chromatography column? Which columns should you choose and what difference does it make to your analyses. Let us help you. This tutorial is broken up into chapters, so you can work through at your leisure or pick and choose the relevant parts you want to listen to.Watch now
Lab Validation and Performance Requirements for the Analysis of PFAS Compounds in Drinking Water
Presenters from Pacific Rim Laboratories and Thermo Fisher Scientific will provide an overview of PFAS analysis using MS/MS for compliance monitoring methods and look at the requirements for the analysis of PFAS in water and soil.Watch now
Perform Like a Pro: Fast ICP-OES Analysis with the Latest Advances
This webcast will focus on the most recent advances in Inductively coupled plasma-optical emission spectroscopy (ICP-OES), address challenges such as ability to analyze high matrix samples restricted to radial only instruments, balance between speed and sensitivity that are faced by analytical chemists and ensure that these challenges are no longer barriers to your trace elemental analysis.Watch now
Non-targeted Screening for Environmental Water Quality Monitoring
In this on-demand webinar, Dr. Andrea Brunner of KWR discusses emerging contaminants and associated challenges and solutions of non-targeted screening for environmental water quality monitoring.Watch now
Terms and Conditions
Thermo Fisher Scientific Pharma 4.0 Giveaway
- 1. NO PURCHASE NECESSARY TO ENTER OR WIN
- 2. The promotion is sponsored by Thermo Fisher Scientific Pte. Ltd, 33 Marsiling Industrial Estate Road 3, #07-06, Singapore 739256 (the “Sponsor”).
- 3. Participation in this event and giveaway is open only to science professionals 18 years and older in Brunei, Cambodia, India (Not applicable in the state of Tamil Nadu), Indonesia, Malaysia, Myanmar, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam, Australia and New Zealand who are one of the first 200 registrants. Employees of Sponsor and its affiliates, as well as their immediate family members and household members, are not eligible.
- 4. Healthcare Professionals may not participate in this promotion. The term Healthcare Professionals includes individuals (clinical or non-clinical physician, including MDs and MDs/Ph.D.s), physician assistants, nurses, technicians, research coordinators, administrators and purchasing personnel) and entities (including hospitals, rehabilitation centres, nursing facilities, home health agencies, clinics and group purchasing organizations, managed care organizations, physician group practices, medical directors for health insurance organizations) and their employees and representatives who are involved in the actual provision of health care services.
- 5. Government Officials may not participate in this promotion. The term Government Official includes anyone who acts in an official capacity for or on behalf of a government entity, department or agency. Void where prohibited, licensed, or restricted by federal, state, provincial, or local laws, regulations, or agency/institutional policy. Determination of eligibility is at Sponsor’s sole discretion.
- 6. To be eligible to win the gift you must complete the registration form and to agree to the Terms and Conditions of Entry between 1st August 2020 and 30th September 2020.
- 7. Two hundred winners (the “Winners”) will be selected on a first-come-first-serve basis from all eligible registration entries between 1st August 2020 and 30th September 2020. The Winners will be notified by email or telephone within 7 working days after the event.
- 8. The Winners will each receive ONE portable coffee maker valued at USD $20. No cash or other substitutions are permitted, except by the Sponsor, which reserves the right to substitute the gift with one of equal or greater value. No refunds or credits are allowed. Gift is not transferable. All taxes on the gift and reporting thereof are the sole responsibility of the Winner.
- 9. If a winner is unreachable or does not make direct contact with the Sponsor by SGT 11:59pm 30th September 2020, or fails to satisfy these terms and conditions or accept the prize, the prize will be forfeited.
- 10. Decision of the Sponsor with regard to any matter arising out of this promotion shall be final, conclusive and binding and shall not be susceptible to any dispute;
- 11. The Sponsor reserves its right to change, discontinue, extend the promotion and/or the terms and conditions thereof without requiring to give any prior notice to the participants;
- 12. To the full extent allowed by law, participants and the Winners release, indemnify and hold harmless the Sponsor and its affiliates, directors, officers and employees from all liability for any damages, injury or losses to any person (including death and bodily injury) or property of any kind resulting in whole or in part, directly or indirectly, from acceptance, possession, misuse or use of the gift or participation in any promotion-related activity or participation in this promotion. The Sponsor has not made any warranty, representation, or guarantee, express or implied, in fact or in law, with respect to any gift, including, without limitation, to such gift’s quality or fitness for a particular purpose. IN NO EVENT SHALL THE SPONSOR BE LIABLE, WHETHER IN CONTRACT, TORT, WARRANTY, OR UNDER ANY STATUTE OR ON ANY OTHER BASIS FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE OR CONSEQUENTIAL DAMAGES SUSTAINED BY ANY WINNER OR ANY OTHER PERSON OR ENTITY ARISING OUT OF THE SPONSOR'S PERFORMANCE OR FAILURE TO PERFORM ITS OBLIGATIONS RELATING TO THE AWARD OF THE GIFT OR PERFORMANCE OF SERVICES, THE POSSESSION OR USE OF ANY PRODUCT, OR THE PERFORMANCE BY THE SPONSOR OF ANY SERVICES, WHETHER OR NOT FORESEEABLE AND WHETHER OR NOT THE SPONSOR IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING WITHOUT LIMITATION DAMAGES ARISING FROM OR RELATED TO LOSS OF USE, LOSS OF DATA, DOWNTIME, OR FOR LOSS OF REVENUE, PROFITS, GOODWILL, OR BUSINESS OR OTHER FINANCIAL LOSS.
- 13. All entries and their content become the property of the Sponsor and will not be returned. By participating the event, you are agreeing to receive further information from the Sponsor in accordance with the Sponsor’s privacy policy, which can be found at thermofisher.com/privacypolicy .
Pharma 4.0-Virtual Learning Series and Live Video Forums
Thermo Fisher Scientific, in collaboration with Separation Science, has developed a virtual learning series with thought leaders from across the world meeting to discuss and explore current and future trends in QbD and PAT and their impact on the laboratory of the future and its connection to manufacturing.
First 200 registrants will receive a portable coffee maker!
*please submit the correct address and phone number to ensure successful delivery of the gift
* terms and conditions can be viewed here
A 'Certificate of Attendance' will be provided to all registered attendees to the virtual learning series and live video forums.
Find out more on this unique learning experience below...
Day 1: Small Molecules
8 September, 2020 - starting at 12.30pm IST / 3pm SGT / 4pm JST
FDA 21 Century Pharma Quality Initiative
Ajaz Hussain (President of The National Institute for Pharmaceutical Technology & Education)
The presentation will cover the importance of understanding Product and Process robustness through effective application of QbD and the vision for the future state for manufacturing and Quality Control laboratories. Dr Hussain will also discuss the history, evolution and impact over the past 16 years – where are we, what’s next and how do we improve.
Continuous Manufacturing: Business Case Drivers, Control and Deployment Strategies for Small Molecule Oral Products
Peter Van Broeck (Scientific Director Small Molecules Pharmaceutical Development, Janssen Pharmaceuticals)
This presentation will examine different elements that can drive the business case of a continuous manufacturing project, and which strategies could be used to deploy this wonderful technology throughout an organization. Also covered will be an overview of the analytical control strategy for a continuous process and its impact on the laboratory
Analytical Technology Innovation in Continuous Manufacturing Science for Small Molecule Tablet Granulation Processes and the Impact on the Laboratory
Martin Warman (Martin Warman Consultancy Ltd and Professor of Practice at University of Strathclyde)
A presentation on the current and unmet analytical needs for in-process testing with specific focus on combining molecular spectroscopy and liquid chromatography. What’s happening today and what needs to change?
Continuous API - What You Need to Know
Malcolm Berry (Chemistry Consulting, UK)
Listen to the thoughts and insights of an API process expert and what you need to know and understand when looking to transform your manufacturing practices from traditional batch to continuous manufacturing.
| Topic | Content | Presenter |
|---|---|---|
| Regulatory Presentation |
FDA 21 century pharma quality initiative • The importance of understanding Product and Process robustness through effective application of QbD and the vision for the future state for manufacturing and Quality Control laboratories • A presentation covering the history, evolution and impact over the past 16 years – where are we, what’s next and how do we improve |
Dr Ajaz Hussain (Ex FDA) – President National Institute for Pharmaceutical Technology and Education (USA) Dr Ajaz S. Hussain began his career in teaching, first at the Ohio Northern University and then at the University of Cincinnati. He then moved to the FDA where he reached the position of Deputy Director Office of Pharmaceutical Science (1995-2004). His most recognizable contribution at the FDA was the establishment of Biopharmaceutical Classification Guidance, championing the PAT and Pharmaceutical Quality for the 21st Century Initiative and serving as the FDA’s lead for quality at ICH and facilitating the progress of ICH Q8, Q9 and Q10. In addition to his role at FDA Dr Hussain has extensive industry experience and a background in academic research and teaching to include several high-level corporate leadership positions. |
| Topic | Content | Presenter |
|---|---|---|
| Small Molecule Presentation (Industry) |
Continuous Manufacturing : Business Case drivers, Control and Deployment Strategies for Small Molecule Oral Products • An overview of the different elements that can drive the business case of a continuous manufacturing project, and which strategies could be used to deploy this wonderful technology throughout an organization • The learning, the overall benefits including an overview of the analytical control strategy for a continuous process and its impact on the laboratory |
Peter Van Broeck - Scientific Director Small Molecules Pharmaceutical Development - Janssen Pharmaceuticals (Belgium) Peter van Broeck is the Scientific Director in Analytical Development at Janssen Pharmaceutica NV, Beerse, Belgium. Since joining Janssen Peter has held several positions including Head of Chemical Process Control and Global Head New Product Introduction. Prior to working at Janssen he had spells with Betz-Dearborn Europe (now GE Water Treatment) and Amylum. His current responsibilities include Continuous Manufacturing strategy deployment lead for Analytical Development (AD), and implementation of new analytical technology/platforms (e.g., process analytical technologies (PAT), Real Time Release testing (RTRt)) and analytical strategy for (small molecules) drug product development/manufacturing. |
| Small Molecule Presentation (Technical |
continuous manufacturing science for small molecule tablet granulation processes and the impact on the laboratory • A presentation on the current and unmet analytical needs for in-process testing with a specific focus on combining molecular spectroscopy and liquid chromatography • What’s happening today and what needs to change? |
Martin Warman - Martin Warman Consultancy Ltd and Professor of Practice at University of Strathclyde (United Kingdom) Martin spent 7 years at Vertex, developing the Vertex continuous manufacturing (CM) platform, on which the first approved CM products are manufactured. He has over 25 years’ experience in the field having previously led the Global PAT Development Team, Pfizer Global Manufacturing. Martin plays an active role in ASTM E55, being the technical lead on standards covering sampling, PAT enabled control systems and continuous manufacturing, is on the ISPE PAT Community of Practice (CoP) global steering committee, and chairs the UK Affiliate PAT CoP. At University of Strathclyde, Martin is an Associate Member of Centre for Process Analytics and Control Technology (CPACT) and supports the CMAC Future Manufacturing Research Hub as well as being the Research Director for the Medicines Manufacturing Innovation Centre (MMIC) being built in Renfrewshire, Scotland, where University of Strathclyde are the Strategic Research partner. |
Developing and Applying Integrated Continuous Bioprocessing Platform to Biologics Development and GMP Production in a Highly Flexible Modular Manufacturing Facility
Process Control and Monitoring for Continuous Production of Biopharmaceuticals
Pharma 4.0-Virtual Learning Series and Live Video Forums
Thermo Fisher Scientific與Separation Science合作舉辦線上論壇，來自世界各地的商務領袖將討論並探索QbD和PAT的現狀與未來趨勢、其對未來實驗室的影響及與製造的聯繫。PHARMA 4.0將匯集來自產業界、學術界和法規界的參與者，討論醫藥和生物技術產品的開發和製造的最新發展、未來趨勢、挑戰和解決方案。
早鳥優惠：前200名完成報名可獲得攜帶式小型咖啡機
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我們將提供“出席證書”給參與線上論壇和圓桌論壇的與會者。
快來了解更多線上論壇的獨家資訊...
圓桌論壇 - 未來實驗室
2020年9月15日– 台灣時間下午3點開始
| Topic | Content | Presenter |
|---|---|---|
| 未來實驗室 | 新研發模型和創新技術所帶來的機會預示著實驗室的變革，科學家能夠快速高效地為患者提供新一代治療方法。此論壇將由專家探討有關最佳實踐及成功整合新技術、協作和創新等問題。考量從批次製造到連續製程的轉變，以及實驗室如何轉移到生產線以進行即時測試。這將對未來的開發和品質控制實驗室產生什麼影響？ |
Moderator • Ernie Hillier Ernie Hillier (主持人, EJH Consulting, 美國) Panelists • Jared Auclair (美國東北大學生物製藥分析與培訓實驗室) • Martin Warman 教授 (英國醫藥製造創新中心) • Shaun Quinn (Thermo Fisher Scientific) • Malcolm Berry (Chemistry Consulting, UK) • Richard Ladd (醫藥顧問, 英國) |
Pharma 4.0-Virtual Learning Series and Live Video Forums
サーモフィッシャーサイエンティフィックは Seperation Scienceと連携して、QbDとPATの現状および将来のトレンド、そしてそれらが未来の研究室へどのような影響を及ぼし、製造にどのようにつなげていくかについて、世界中のオピニオンリーダーと討議するバーチャルラーニングシリーズを展開します。「Pharma 4.0」は、産業界、学術界、規制当局からの参加者を集めて、医薬品やバイオテクノロジー製品の開発と製造の最新状況および将来のトレンド、課題、ソリューションについて討議できる貴重な機会を提供します。
ライブ・ビデオ・フォーラム -未来の研究室
2020年9月15日—12:30 IST/15：00 SGT/16:00 JSTからスタート
| Topic | Content | Presenter |
|---|---|---|
| 未来の研究室 | 新しい研究開発モデルと画期的な技術は、研究室に変革をもたらし、科学者が次世代の治療法を迅速かつ効率的に患者に提供することを可能にします。このフォーラムでは、ベストプラクティス・新技術の導入の成功事例・コラボレーションおよびイノベーションに関する問題について、専門家に聞きます。大量生産から連続生産への移行と、リアルタイムの試験を可能にするために研究室がどのようにラインに組み込まれるかを考えてみましょう。これは将来の開発とQC研究室にどのような影響を与えるのでしょうか。 |
Moderator • Ernie Hillier (Principal, EJH Consulting, USA) Panelists • Jared Auclair (Northeastern University Biopharmaceutical Analysis & Training Lab) • Prof. Martin Warman (UK Medicine Manufacturing Innovation Centre) • Shaun Quinn (Thermo Fisher Scientific) • Malcolm Berry (Chemistry Consulting, UK) • Richard Ladd (Pharmaceutical Consultant, UK) |
Pharma 4.0-Virtual Learning Series and Live Video Forums
써모 피셔 사이언티는 Separation Science과 공동으로 전세계의 업계 리더들이 모여 현재와 미래의 QbD 및 PAT 트렌드와 그것이 미래의 실험실 및 의약품 제조에 미치는 영향을 논의하고 연구하는 온라인 강의 시리즈 를 개발했습니다. PHARMA 4.0은 업계, 학계 및 규제 기관의 참가자들이 의약품과 생명공학 제품의 개발과 제조에서의 난제 및 해결책, 앞으로의 트렌드, 최신 개발품들에 대해 토론할 수 있는 귀중한 기회가 될 것입니다.
선착순으로 등록하신 200분께 휴대용 커피 메이커를 선물로 드립니다!
*물품 배송을 위하여주소와 전화번호를 정확히 기재 부탁 드립니다.
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등록 후 온라인 강의 시리즈 및 라이브 비디오 포럼에 참석한 모든 참석들에게는 "참석 증명서"를 제공합니다.
온라인 강의에 대한 상세 정보는 아래에서 확인하십시오.
라이브 비디오 포럼- 미래의 실험실
2020 년 9 월 15일- 시작 시간: 오후 12시 30 (IST) / 오후 3시 (SGT) / 오후 4시 (JST)
| Topic | Content | Presenter |
|---|---|---|
| 미래의 실험실 | 새로운 R&D 모델과 혁신 기술로 인한 기회는 실험실의 변화를 예고하여 과학자들이 환자에게 차세대 치료를 신속하고 효율적으로 제공할 수 있게 합니다. 이 포럼에서는 모범 사례, 새로운 기술의 성공적인 통합, 협업 및 혁신과 관련하여 주요 전문가들에게 질문할 것입니다. Batch 기반의 제조에서 연속 공정으로 전환하고 실험실이 실시간 테스트를 위해 라인으로 이동하는 방법을 소개합니다. 이것이 개발 그리고 미래의 QC 실험실에 어떤 영향을 미칠까요? |
Moderator • Ernie Hillier (미국 EJH Consulting 사장) Panelists • Jared Auclair (북동부 BATL(바이오 제약 분석 및 교육 연구소) 소장) • Prof. Martin Warman (Martin Warman Consultancy Ltd 및 Strathclyde 대학교 임상 교수) • Shaun Quinn (Thermo Fisher Scientific) • Malcolm Berry (Chemistry Consulting, UK) • Richard Ladd (영국 의약품 컨설턴트) |
A Virtual LCMS Conference Designed for the Masses: your fast track to confident results
Welcome to the Thermo Fisher Scientific virtual LCMS Conference – an exclusive event on state-of-the-art mass spectrometry with a focus on Orbitrap technology and beyond. The switch between exploration and targeted quantitation has never been easier. Scale up your research and translate your results more rapidly and simply than ever before.
Join us at our virtual conference to:
• Attend plenary presentation by Professor Alexander Makarov – “Designing the Smallest Ever Orbitrap Mass Spectrometer for New HRAM Applications”.
• Learn and gain valuable insights from mass spectrometry experts about Orbitrap mass spectrometry technology and the applications it enables.
• Explore the LCMS portfolio and meet the expanded Orbitrap Exploris MS systems in our Exhibit Hall and dedicated booths.
• Venture into our poster vault for numerous poster presentations.
• Learn about new releases and more
On-demand conference presentations will be available in English, 日本語 and 한국어.
Virtual LCMS Conference Agenda
Explore sessions tailored to your interest:
English |
|---|
| Designing the Smallest Ever Orbitrap Mass Spectrometer for New HRAM Applications Professor Alexander Makarov | Thermo Fisher Scientific |
| Your fast-track to confident results: Thermo Scientific Orbitrap Exploris product family expanded Dr. Thomas Moehring | Thermo Fisher Scientific Demonstrating the new Orbitrap Exploris 120 Dr. Ed George | Thermo Fisher Scientific |
| Proteomics on Orbitrap Exploris 240 MS - Moving beyond peptide IDs - A New, Versatile and Robust Compact Benchtop Orbitrap For Quantitative Proteomics Applications Dr. Peter Mowlds | Thermo Fisher Scientific |
| Analysis of Nitrosamines on Thermo Scientific Q Exactive Plus and Thermo Scientific Orbitrap Exploris 120 Dr. Olaf Scheibner | Thermo Fisher Scientific |
| Orbitrap and the IDX platform: The Foundation of Scientific Confidence, Versatility and Excellence for RASL Paul Zahra | Racing Analytical Services Limited (RASL) Co-presenter Dr. Steve Binos | Thermo Fisher Scientific |
| Next-generation Orbitrap Exploris Mass Spectrometers for sensitive Qualitative and Quantitative PFAS analysis Dr. Neville Llewellyn | Thermo Fisher Scientific |
| MS-based Clinical Proteomics Workflow from Discovery to Validation Dr. Sanjeeva Srivastava | Indian Institute of Technology Bombay, Mumbai |
| Identification of Bioactive Compounds using LC-HRAM-MS for Food Authentication Dr. Hong-Jhang Chen | National Taiwan University |
日本語 | Japanese |
|---|
| DIAによる超深度プロテオーム解析への挑戦 川島 祐介 (Dr. Kawashima Yusuke) | 公益財団法人かずさDNA研究所 (Kazusa DNA Research Institute) |
| 網羅的な同定から定量まで、Orbitrap Exploris 240によるプロテオミクス アプリケーションのご紹介 渡邊 史生 (Mr. Watanabe Shio) | サーモフィッシャーサイエンティフィック株式会社 (Thermo Fisher Scientific) |
| Orbitrap Exploris シリーズによる定量アプリケーションのご紹介 山元 良馬 (Mr. Yamamoto Ryoma) | サーモフィッシャーサイエンティフィック株式会社 (Thermo Fisher Scientific) |
| 探索からルーチンまでカバーするバイオ医薬品特性解析ソリューションのご紹介～ウイルス、抗体から核酸まで～ 肥後 大輔 (Mr. Higo Daisuke) | サーモフィッシャーサイエンティフィック株式会社 (Thermo Fisher Scientific) |
| 新製品のご紹介：低分子定性に有用な機能とソフトウエアのご紹介 石橋 愛実 (Ms. Ishibashi Megumi) | サーモフィッシャーサイエンティフィック株式会社 (Thermo Fisher Scientific) |
한국어| Korean |
|---|
| HRAM Orbitrap 기술을 이용한 프로테오믹스 연구 소개 Dr. Jong-Seo Kim | Seoul National University (Center for RNA Research, IBS) |
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