Newsletter | December 14, 2023

12.14.23 -- FDA Sets Recommendations For Predicting Nitrosamine Impurities

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FEATURED EDITORIAL

Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2

By Allan Marinelli and Howard Mann

This article, part two of a three-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.

FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

By D. Farquhar and R. Lewis, Hyman, Phelps & McNamara

The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

INDUSTRY INSIGHTS

Leveraging Autoinjector Innovation To De-Risk Biosimilar Development

Article | By Victoria Meyer, MBA, BD Medical - Pharmaceutical Systems

Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.

Tips For Purifying Cryo-EM Samples

Webinar | By Kristin Lenberg, Cytiva

Cryo-electron microscopy can help you determine structures for challenging proteins such as membrane proteins and larger complexes. This presentation offers tips on purifying your cryo-EM samples.

Cut Through Complexity, Gain Speed, And Get Your Drug To Patients ASAP

e-book | West Pharmaceutical Services, Inc.

Discover top challenges that emerging biologics face, packaging containment offerings and services that help mitigate risks, and ways to reduce obstacles that slow development.

NEWS HEADLINES

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FDA Approves Bio-Thera Solutions' Avzivi (bevacizumab-tnjn), A Biosimilar Referencing Avastin

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Health Canada Approves FYB201/Ranopto (Ranibizumab), A Biosimilar To Lucentis

SOLUTIONS

Storing Your Banks With Ease And Confidence

MilliporeSigma Biosafety Testing Services

BD Physioject 1 mL Disposable Autoinjector

BD Medical - Pharmaceutical Systems

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