Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design
Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.
Design space generation is encouraged in new product development.
Program review can help quality risk management live up to the promise of ICH Q9.
Careful selection of downstream processing conditions is a must.
Part II of this three-part series presents a roadmap to human error prevention.
Single-use products offer options and choices for biopharma mixing.
Going beyond pharmacopeial requirements is essential for the quality and safety of raw materials.