Separation Science Pharmaceutical offers free learning from the experts covering methods, applications, eBooks, webinars, eSeminars, expert forums, videos, tutorials and training for pharmaceutical analysis users of chromatography, mass spectrometry, spectroscopy, sample preparation and related analytical techniques.
Featured Educational Resources
Fast and Selective Purification of Oligonucleotides
Video & Application Note
Florian Rieck (Agilent Technologies)
Join Dr Florian Rieck in a short presentation as he introduces a method for the fast and selective purification of oligonucleotides. The complementary application note, which is available for download, describes a purification method with MSD that uses alternative, less costly reagents. Target compounds were collected faster and with higher purity compared to conventional methods.
Computerized System Validation: GAMP 5 2nd Edition, What You Need to Know
Michael Korbel (Global Sr. Product Manager, Agilent Technologies, Inc.)
In this webinar we look at the contents of the long awaited GAMP®5 Version 2 release to examine what has truly changed since the Version 1 release, with special focus on what might impact regulated laboratories in the pharma, biopharma, and biotech industries.
Evolution of USP<1058> updates and insights in regulations
Paul Smith (Agilent Technologies, Inc.)
Many laboratories are not currently complying with the 2017 edition of USP <1058> and plans are already in progress to initiate further updates. This presentation addresses many of the questions about the role of the current <1058> general chapter and how it aligns with the recently issued 2nd Edition of GAMP® 5.
(U)HPLC Analysis of Biopharmaceuticals: Quality Attributes and How to Analyse Them
Andrea Krumm (Tosoh Bioscience)
In this tutorial series you will learn the basics of (U)HPLC analysis of biotherapeutics, such as monoclonal antibodies and other proteins. We explain which critical quality attributes need to be analyzed and which (U)HPLC methods are suitable for these purposes. In addition, we provide tips and tricks from our chromatography experts for successful method development.
Accelerating Large-scale Proteomics with High-throughput Accurate Mass Spectrometry Workflows
Dorte Bekker-Jensen (Evosep Biosystems) and Patrick Pribil (SCIEX Proteomics Applications Development)
This presentation discusses high-throughput mass spectrometry workflows for large-scale qualitative and quantitative proteomics. It explores the rapid adoption of data-independent acquisition (DIA or SWATH DIA) approaches, such as Zeno SWATH DIA: a method that achieves 5-6x more MS/MS sensitivity, resulting in this DIA approach surpassing data-dependent acquisition (DDA) for protein identifications and quantification in complex matrices.
[Application] Analysis of Lipid Nanoparticle Composition
Dr. Sonja Schneider (Agilent Technologies)
This application note describes the analysis of the lipid components of patisaran using an Agilent 1260 Infinity II Prime Bio LC system and evaporative light scattering detection (ELSD). Read the application to learn about composition and structure of lipid nanoparticles, how to achieve best LC separation for the LNP components, and how to use the ELSD for universal detection.
Valisure’s Identification of Benzene as a Pervasive Contaminant in the Consumer Products Industry
David Light and Kaury Kucera (Valisure)
This presentation describes the identification of benzene in a variety of consumer products, such as hand sanitizers, sunscreens and body sprays and how Valisure provides independent quality assurance throughout the supply chain.
Electron Activated Dissociation (EAD) MS/MS for the Structural Elucidation of Lipids
Sophia Laposchan (Technical University of Munich, Germany)
By viewing this presentation you will gain a basic understanding of using electron activated dissociation in MS/MS analysis for structural elucidation of lipids; and learn how EAD can distinguish structural isomers of various lipid classes and how this powerful technique adds value over other fragmentation techniques.
Detection and Quantification Challenges of Trace Level Impurities in Pharmaceutical Products - Mutagenic Nitrosamines and Beyond
Multi-speaker event (Novartis, EMD Serono, AstraZeneca, US Pharmacopeia) sponsored by VUV Analytics
This on-demand discussion forum covers the risk assessment and analytical challenges of detection and quantification of trace level impurities in pharmaceutical products.
The Importance of Data Integrity in Achieving Pharma 4.0
Nicola Gardner (Thermo Fisher Scientific)
In this presentation we explore why organizations cannot continue to advance with only technology and must also understand the evolution of data integrity.
Handheld Raman Solutions for Raw Material ID
Richard Crocombe, Bülent Üstün, Ali Saleemi, Pierre-Yves Sacre and Mike Claybourn
Learn about the transformative power of handheld instruments in terms of instant actionable data and associated return on investment; key benefits of spatially offset Raman spectroscopy (SORS) for raw material ID; advantages of moving from laboratory-based testing to testing using handheld devices in the warehouse; the relative merits of handheld Raman and NIR; and challenges in method development and building models.
Advance with Transmission Raman
Dr Julien Villaumie, Prof. Martin Warman, Dr Gary McGeorge and Mark Godfrey
Learn about the benefits for targeted implementations of TRS in pharmaceutical development and manufacture, the route to implementation of TRS and the regulatory submission for manufactured products, the important role of HPLC for successful quantitative TRS method development and verification, and the barriers and challenges including cultural, regulatory, and scientific.
Effective Nitrosamines Analysis in Drugs and Solvents
Discover methods for the quantitation of various nitrosamines in drugs and solvents using Shimadzu LC/MS or GC/MS instruments, including: 1) Quantitation of 6 Nitrosamines in 5 Sartans by LC-MS/MS system as per the proposed USP General Chapter <1469>, 2) Quantitation of 6 Nitrosamines in Losartan API by LC-MS/MS system as per the proposed USP General Chapter <1469>, 3) Quantitation of 7 Nitrosamines in API by HSGC-MS/MS as per proposed USP General Chapter <1469> and 4) Quantitation of 8 Nitrosamines in 12 different solvents by LC-MS/MS system.
Solutions for COVID-19 Drug Analysis
Discover methods for the analysis of various therapeutics for the treatment of COVID-19, including: 1) Simultaneous Analysis of Remdesivir and Metabolites in Human Plasma Using Fully Automated Sample Preparation LC/MS/MS System, 2) Simultaneous Analysis of Remdesivir and Metabolites in Human Plasma (LC-MS), 3) Fully Automated Quantification of Meropenem, Tazobactam, Piperacillin and Dexamethasone in Plasma and 4) JP- and EP-Compliant Analysis of Impurities of COVID-19 Drug Dexamethasone.
How Can LIMS Deliver Value to Your Pharma Manufacturing Lab?
Daren Cumberbatch & June Tham (Thermo Fisher Scientific - Digital Science)
This on-demand webinar focuses on how laboratory information management systems (LIMS) can deliver value and efficiency, and increase productivity, in your pharmaceutical manufacturing laboratory.
Analytical Methodologies for Nitrosamines: Challenges and Solutions
Dr. BM Rao (Dr. Reddy's Laboratories Limited)
This on-demand webinar presents a case study of risk assessment implementation and covers analytical methodologies for N-nitrosamines with their challenges and suggested solutions. By watching this presentation you will: 1) Get background information on risk assessment and control of N-nitrosamine contamination in drugs, 2) Understand method development approaches and how to deal with the challenges and 3) Learn to overcome analytical challenges presented by APIs and drug products.
NPS Screening and Identification: Nominal and Accurate Mass Approaches for Ultimate Success
Pierre Negri (SCIEX)
In this webinar, the presenter will discuss how nominal mass and accurate mass instruments can be used in forensic toxicology workflows as two different yet complementary approaches for screening and identifying novel psychoactive substances (NPS). The two different LC-MS/MS platforms will be presented with an explanation of how they are used strategically for the detection and identification of NPS with a high level of sensitivity and specificity.
Opioids: Choosing the Best Solution for your Laboratory On-demand
Jillian Neifeld (Applications Chemist, Biotage)
This webinar provides sample preparation solutions for synthetic opioids analysis in forensic laboratories. The presentation covers the opioid epidemic, extraction techniques to include supported liquid extraction and solid-phase extraction, matrices that can be analysed with these techniques, as well as results obtained from the various extraction types.
One Size Does Not Fit All: Considerations for Minimizing Matrix Effect and Maximizing Recovery for Clinical Panels Large and Small
Dr Lee Williams (Biotage GB Limited)
This webinar will discuss typical clinical matrices such as whole blood, plasma, serum, urine and oral fluid with specific emphasis on a variety of endogenous components. Matrix complexity will be illustrated and related to a variety of clinical assays, demonstrating potential impact on method robustness. Examples will be presented detailing challenges involved for large panel analysis.
A Guide to Updating HPLC Compendial Methods in Pharmaceutical Analysis
William J. Long (Agilent, USA)
This webinar will discuss how changes to compendial methods, known as adjustments, are made for HPLC separations and how these adjustments can be made with or without validation. Basic (ICH) validation guidelines will also be covered.
Get more information in less time: a routine and sensitive workflow for peptide mapping and PTM analysis
Linfeng Wu (Application Scientist, Agilent Technologies) & Ning Tang (Biopharma Segment Marketing Manager, Agilent Technologies)
You will learn how an integrated peptide mapping workflow solution automates and streamlines the complex process from sample preparation to data analysis, how a new LC/Q-TOF acquisition method–Iterative MS/MS– makes method optimization easy and improves the sensitivity and confidence for low abundant peptide, and how this integrated workflow makes identification and quantification for PTM peptides fast and simple.
Easy Characterisation Workflows in Therapeutic Protein Analysis - Emphasis on Global and Multi-attribute Techniques
Ken Cook (Thermo Fisher Scientific, UK)
This webinar will detail how new technologies can deliver peptide mapping which is fast, easy for untrained operators, reproducible and transferable, easy to automate and provides high-quality results with low PTMs.
Accelerate Your Throughput and Be More Productive with State-of-the-Art ICP-MS Instruments
Richard Jack and Daniel Kutscher (Thermo Fisher Scientific)
This webinar will demonstrate how modern ICP-MS instruments can help with analysis of trace elements in routine focused laboratories. The presentation will also show how key metrics including turnover time per sample or maintenance required downtime can be reduced without compromising system performance.
Light Scattering Techniques for Protein and Polymer Characterization
Need to understand how modern analytical techniques can help you measure absolute molar mass and sample size - this educational portal offers methods and applications of light scattering techniques in combination with size-exclusion chromatography and field-flow fractionation for characterizing proteins, polymers and more...
Innovators & Biosimilars: Fast Glycan Labeling and Analysis
András Guttman (SCIEX)
This presentation will discuss the importance of glycan analysis of biotherapeutics, how capillary electrophoresis has been established as a routine analytical platform, and introduce an award-winning fast glycan labelling and analysis technology. Features such as fast automated sample preparation, fast separation times, the simplicity of analysis and fully automated data analysis and glycan identification will be covered.
Trends and Applications in the Analysis of Biotherapeutics & Biosimilars
Separation Science, in collaboration with Agilent Technologies, has developed an on-demand eSeminar covering analytical trends and novel applications of chromatography and mass spectrometry to the characterization of biotherapeutics and biosimilars. The eSeminar comprises 8 presentations, including: 1) Make your Protein Talk - How does the AdvanceBio Q-TOF Deliver More Information?, 2) Rapid, Powerful Technologies to Address Peptide Mapping Challenges, 3) Characterizing Critical Quality Attributes - Developing Workflow Solutions for Charge Variants and Aggregation Quantification, 4) High Order Structural Characterization by CE-MS, 5) Discover Single-Digit ppm Host Cell Proteins in Purified Antibody Samples, 6) Analysis of mAb N-glycans by HILIC with Fluorescence Detection and Online Mass Selective Detection, 7) More than Just Increasing Peak Capacity - Agilent 1290 Infinity II 2D-LC Solution for the Analysis of Biopharmaceuticals, 8) Qualitative Assessment of Extractables from Single-Use Components Employed in the Storage or Manufacture of Biopharmaceuticals
Learning portal for Biopharmaceutical Applications covering SEC, HILIC, (U)HPLC, UHP-SEC
Tosoh Bioscience has produced its 'Biopharmaceutical Application Notebook' for the (U)HPLC analysis of biomolecules. This essential application notebook will keep you informed of all the latest developments in the biopharmaceutical industry using both high-performance liquid chromatography and ultra-high performance liquid chromatography — the analytical workhorses of the pharmaceutical industry.
HPLC for Biopharmaceuticals - Training Course
Self-paced online course with validated learning and certificate of completion
Analytical Training Solutions | Separation Science
Although “small molecule” and “biopolymer” separations have traditionally been considered as separate activities, analysts in the biopharmaceutical industry regularly have to deal with both. Fortunately, the underlying principles of chromatography apply equally well in both situations when interpreted appropriately. 'Practical HPLC for Biopharmaceuticals' explains chromatography in practical terms from the ground up. Here’s what you’ll learn in this online course: The basics of isocratic and gradient HPLC, Reversed-phase and ion exchange HPLC, HPLC equipment – from reservoirs/pumps to tubing/injectors to columns and detectors, Understanding and overcoming common column problems, Alternative modes: normal phase, HILIC and size exclusion, Quantitation, UHPLC, Performance qualification, Troubleshooting and diagnostics.
PHARMA 4.0 - 2020: Transforming Pharmaceutical Manufacturing
Technology, Innovation & Impact on the Laboratory
Separation Science developed a virtual learning series with thought leaders from across the world 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. PHARMA 4.0 – 2020 brought together participants from industry, academia and regulatory to create an invaluable opportunity to discuss the recent developments, future trends, challenges and solutions for the development & manufacturing of pharmaceutical & biotechnology products.
Complementing the PHARMA 4.0 – 2020 virtual learning series are three round table Forums, each covering a topic key to this field – Lab of the Future, Emerging Technologies, and Regulatory and Quality Challenges.