Bioprocessing emerged from a history of extensive testing for quality assurance, but some of that is changing. Instead of an industry built on quality by testing (QbT), bioprocessing would benefit ...

In the past 10 years, the pharmaceutical industry has been moving towards a design space approach to development and manufacture – an approach that has been defined by ICHQ8, Q9 and Q10, and the ...

Luxury or necessity for developing the best biologicals? “There is the perception in biopharm companies that it is too expensive and takes too much time to implement full QbD (Quality by Design) for ...