The growth of single-use technology (SUT) has revolutionized the bioprocess industry. The implementation of single-use technology (SUT) has typically been a trial and error exercise for the end users. A publication that provides a road map for...
Process characterization is an essential step in the commercialization of a new (biological-) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures, that the manufacturing process delivers...
1 Background and Purpose 1.1 Team Composition The authors are members of the ISPE global PAT COP Data Management Task Team. The mission of the Team is...
CMC Biotech Working Group Version 2.1 This is a detailed case study to stimulate discussion around how the core principles contained in Q8(R2), Q9 and...
