Using Product Lifecycle, Process Validation, and Quality by Design (QbD) Paradigms to Efficiently Take New Biopharmaceutical Products from Pre-IND to Commercial Manufacturing

by Mark F. Witcher, PhD
Volume 14, Issue 1 (Spring 2015)

This paper describes how a biopharmaceutical product development effort can be structured to identify, understand, and plan activities and goals required to efficiently and rapidly deliver new products and therapies to patients. Although the paper focuses on manufacturing, the approach can be used for all aspects of pharmaceutical product development from establishing an intellectual property position, developing a comprehensive manufacturing plan, to creating a marketing program.

Witcher MF. Using product lifecycle, process validation, and quality by design (QbD) paradigms to efficiently take new biopharmaceutical products from pre-IND to commercial manufacturing. BioProcess J, 2015; 14(1): 30–5.

Posted online April 15, 2015.