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Pharmaceutical Analysis

Separation Science Pharmaceutical Analysis offers free learning from the experts covering methods, applications, webinars, eSeminars, videos, tutorials for pharmaceutical analysis users of chromatography, mass spectrometry, sample preparation and related analytical techniques.

PHARMA 4.0: Transforming Pharmaceutical Manufacturing


Technology, Innovation & Impact on the Laboratory

Separation Science has developed a virtual learning series with thought leaders from across the world meet 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 will bring together participants from industry, academia and regulatory to create an invaluable opportunity to discuss the recent developments, future trends, challenges and solutions for development & manufacturing of pharmaceutical & biotechnology products.

Complementing the PHARMA 4.0 virtual learning series will be three round table Live Forums, each covering a topic key to this field – Lab of the Future, Emerging Technologies, and Regulatory and Quality Challenges.

Coming soon! FREE On-demand access to this unique learning experience.


Featured Educational Resources

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


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.

USP Monograph Modernization & Ion Chromatography Portal

Educational Microsite

Multi-Speaker Event

A monograph is a written document, or standard, that describes an item (e.g., a finished drug, a drug ingredient, impurity or excipient). Many of the existing pharmaceutical and biopharmaceutical assays (e.g., those from the United States Pharmacopeial Convention [USP], and other pharmacopoeias) are time-consuming, labour-intensive, involve hazardous chemicals, require extensive analyst training, and may yield significant measurement errors. In recognition of this, the USP embarked on a monograph modernization initiative, aligned with the methods in other pharmacopoeias and the International Conference on Harmonization (e.g., ICH Q3A and Q3B), and current FDA guidance. Ion chromatography (IC) plays a key role in drug monograph modernization because it offers a significant improvement to existing active pharmaceutical ingredient, impurity and counterion assays, with advantages in speed, reproducibility, accuracy, safety and cost-effectiveness. This learning portal, produced in collaboration with Thermo Fisher Scientific, provides learning content, advice and guidance for the transition to modernized pharmacopoeial methods using IC.

Practical HPLC for Biopharmaceuticals

Self-paced Online Training

Analytical Training Solutions

'Practical HPLC for Biopharmaceuticals' explains chromatography in practical terms from the ground up. You will acquire a good understanding of the practicalities of HPLC and how it can be used in the analysis of biopharmaceuticals. What you learn will demystify the role of liquid chromatography in the analysis of biopharmaceuticals.

Protein Analysis with Size Exclusion Chromatography (SEC)

Educational Microsite

GE Healthcare

Size exclusion chromatography (SEC) is currently the most powerful chromatography technique for obtaining reliable information about the size of biomolecules under native conditions. As such, it is widely used in several different analytical applications from basic research to quality control of biotherapeutics. This educational microsite presents fundamentals about analytical SEC, tips to ensure successful analysis, available products and applications showcasing the role of SEC in biomolecule analysis.

FREE learning from the experts!

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Latest Blog Posts

Pharmaceutical Analysis Blog

Separation Science Biopharmaceutical Analysis

Visit Separation Science Biopharmaceutical Analysis for free learning from the experts for analytical scientists working in biopharmaceutical laboratories, covering amongst others:

— Protein & Peptide Analysis

— Biologics & Biosimilars

— Glycan Analysis

— Aggregate Analysis

— Charge Variant Analysis

— Biopharmaceutical Analysis Methods & Applications

— Biopharmaceutical Analysis Webinars & eSeminars

— Biopharmaceutical Analysis Videos & Tutorials