Newsletter | July 25, 2019

07.25.19 -- Global Biosimilar Development: Progress & Pitfalls

Featured Editorial
The Progress And Pitfalls Of Global Biosimilar Development
By Anna Rose Welch, editor, Biosimilar Development

While we’ve certainly seen progress on the march toward true global development, there’s still a long way to go. There were several points I learned recently that stood out about which regulatory inconsistencies still exist between developed nations, as well as how certain aspects of regulatory science can be improved upon in the future.

Off-Site Modular Fabrication Of Biopharma Facilities: What You Need To Know
By Hector M. Samper, Global Strategic Sourcing Solutions (GSSS)

Measurable benefits of off-site module construction are becoming more evident, and it is emerging as a viable method for delivering a greater degree of predictability. Furthermore, market constraints driven by shortages of craft labor, lagging productivity, project complexity, and competitive forces are contributing to biopharma’s move toward modularization.

Industry Insights
Process Effects On Drug Product Quality In Pharmaceutical Manufacturing: A Validated Measurement Process
White Paper | GE Healthcare Life Sciences

This white paper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes and how a systematic approach with validated SPR assays can help in this respect.

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