As described in ICH Q5A on virus safety of biotechnological products (1) and the European guideline on virus safety of biotechnological products, EMEA 398498 (2), viral clearance studies are mandated as part of the viral safety evaluation of products derived from human or other mammalian cell lines. When acceptable ranges of process parameters are known, both guidelines recommend that scale-down models be evaluated under worst-case conditions for viral clearance. The BioPhorum Development Group’s viral clearance workstream performed a benchmarking survey…
Author Archives: Dhiral A. Shah
Manufacturability Assessment: A Tool for Effective and Transparent Decision-Making and Efficient Process Development
Design for manufacturing (DfM, also known as design for manufacturability) is a common approach in engineering industries when complex, multistep production processes are developed and installed to manufacture products. Adherence to DfM approaches has been prevalent for decades in the automotive, aerospace, and electronics industries, among others (1–3). Recently, a generalized manufacturability-assessment tool with strategies to weigh different aspects of manufacturing has been proposed with numerous similarities to that described herein specific to the field of bioprocess development (4). Although…