Home / Pharma / Blog

Pharmaceutical Analysis

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.

Stay ahead and improve your skills! Receive tailored information on new separation science methods and applications.Register for free learning now >>

Featured Educational Resources

Glycan Analysis in Biopharma: Challenges & Future Directions

19 & 20 October, 2022

Arnaud Delobel (Quality Assistance S.A.), Pauline Rudd (BTI AStar Singapore, GCon consultancy), Gordan Lauc (Genos), Michael Butler (NIBRT), James Duffy (LabCorp)

In this event we bring together industry leaders who will present their approaches to the challenges of glycosylation analysis, focused on biotherapeutics and biomarkers. This will include an introductory scene-setting presentation followed by an expert discussion with participants providing their insights into current trends in glycan analysis, key analytical challenges facing the industry, and future directions in the field.

Valisure’s Identification of Benzene as a Pervasive Contaminant in the Consumer Products Industry

On-demand

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

On-demand

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

On-demand

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

On-demand webinar

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

On-demand webinar

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

On-demand webinar

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

Application Note(s)

Shimadzu Corporation

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

Application Note(s)

Shimadzu Corporation

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?

On-demand webinar

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

On-demand webinar

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

On-demand webinar

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

On-demand webinar

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

On-demand webinar

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

On-demand webinar

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

On-demand webinar

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

On-Demand webinar

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

On-Demand webinar

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

On-demand webinar

Various speakers

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

On-demand webinar

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

On-demand eSeminar

Multi-Speaker Event

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

Educational Microsite

Tosoh Bioscience

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.

FREE On-demand access to this unique learning experience.

Latest Blog Posts

Pharmaceutical Analysis Blog

Stay ahead and improve your pharmaceutical analysis skills!

Follow us on Twitter: @Sep_Science

Be the first to know as our team will send straight to your inbox tailored information on new separation science methods and applications.