A Qualitative Risk-Benefit Structure for Developing and Manufacturing Biopharmaceuticals

by Mark F. Witcher, PhD
Volume 14, Issue 3 (Fall 2015)

Developing and manufacturing biopharmaceuticals is a complex endeavor that will become even more challenging as the field of medicine expands into a broader range of therapies that includes cellular, genetic, epigenetic, and proteins with more specific biomarkers and functions. New manufacturing process technologies utilizing single-use systems, high-performance perfusion bioreactors, and continuous/semi-continuous processing will add further complexity. To better serve the patient population, a biopharmaceutical development and manufacturing enterprise should address all of the patient’s needs. The enterprise must minimize the therapy’s safety risks while providing the benefits of timely, efficient, and reliable access to effective biopharmaceutical products. Achieving the benefits while controlling patient risks can be aided by understanding a qualitative risk-benefit structure that defines the quality of the product in terms of its overall value to the patient. This paper seeks to begin the process of developing a comprehensive risk-benefit structure that can be used by a biopharmaceutical development-manufacturing enterprise to successfully develop and optimize a therapy’s value...

Witcher MF. A qualitative risk-benefit structure for developing and manufacturing biopharmaceuticals. BioProcess J, 2015; 14(3): 4–12. http://dx.doi.org/10.12665/J143.Witcher.

Posted online October 9, 2015.