Newsletter | February 2, 2023

02.02.23 -- Why Location Matters In CDMO Selection
 
Featured Editorial
CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance
 
By Ryan Murray, M.Sc., and Amanda McFarland, M.Sc., ValSource, Inc.

While the concept of contamination control is not new, the EU's revised GMP Annex 1 requires a formally documented strategy specific to a facility. Under the new set of requirements, the “span of oversight” has shifted, and CDMOs are finding their sterility assurance programs in a position that will require a new level of transparency with sponsors.
Why Location Matters In CDMO Selection
 
By Paul Eschmann, Basel Area Business & Innovation

While many factors can dictate the choice of a CDMO partner, the CDMO's location can have a significant influence on the communications channels, facilities, and skillsets that a potential partner has to offer.
Industry Insights
Is Your Biologic At Risk For Protein Aggregation? Part 1
Article | By Martin Gonzalez, Ph.D., Pfizer CentreOne

This is the first installment in a three-part series that examines the causes of protein aggregation and practical steps you can take to mitigate the risk.
Technology Transfers: A Beginner's Guide
Article | By Lei Zheng, Pfizer CentreOne

You may have questions or knowledge gaps regarding technology transfers. To help your understanding, we’ve compiled a beginner’s guide to technology transfer fundamentals.
Analytical Services: Risk Management In PFS Components Selection
Poster | By Claire Brunet, Filippo Conti, and Pauline Romain, BD Medical - Pharmaceutical Systems

Choosing the right containers and materials is critical but difficult, and no methodology can quickly assess the risk of drug/device interaction. Two risk-based test methodologies help to select the optimum closure materials and the correct syringe silicone level at the early phase of drug development.
Fluid Flow Effects In A Chromatography Column For Mechanistic Models
Article | Cytiva

Flow patterns are three-dimensional in space, and chromatography fluid dynamics (CFD) models should also be three-dimensional in space. Understand fluid dynamics within a chromatography column.
Higher Order Structure Of Proteins By Circular Dichroism Spectroscopy
Application Note | MilliporeSigma Biosafety Testing Services

Learn more about the analytical development for mAbs and recombinant proteins.
Managing Container-Closure Related Complexities With Lyophilized Drug Products
Webinar | West Pharmaceutical Services, Inc.

Using a comprehensive approach to component selection mitigates risks to fill/finish and lyo processing. Explore key considerations for selecting lyophilization stoppers suitable for intended use.
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