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.
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.
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.