Achieving Excellence in Biopharmaceutical Development and Manufacturing by Using Appropriate Manufacturing Practices (AMPs)

by Mark F. Witcher, PhD
Volume 14, Issue 4 (Winter 2015/2016)

Biopharmaceutical manufacturing will continue to be increasingly challenging as medical knowledge and understanding rapidly advance. Many new therapies and products will utilize cellular, viral, genetic, and epigenetic approaches along with a repertoire of increasingly complex proteins targeting a rapidly increasing inventory of newly discovered biomarkers. Manufacturing these products efficiently, consistently, and reliably will require sophisticated manufacturing approaches, methods, and controls. In addition, growing patient, societal, and even regulatory pressures demand that new therapeutics be developed and manufactured quickly, reliably, and efficiently. Historically, manufacturing has been viewed and managed in terms of minimizing patient safety risks. The focus has been on not harming the patient through inadequate manufacturing practices and controls. This approach is the basis for regulatory defined current good manufacturing practice (cGMP) guidelines that establish minimum standards and practices for regulatory oversight to assure product quality...

Witcher MF. Achieving excellence in biopharmaceutical development and manufacturing by using appropriate manufacturing practices (AMPs). BioProcess J, 2016; 14(4): 30–6.

Posted online January 12, 2016.