Cell Culture & Upstream Processing / Manufacturing Strategy
Industry Initiative for Raw Material Risk Assessments
An industry-wide effort facilitated by BPOG is underway on raw material risk assessment. The goal is to leverage industry experience across multiple modalities, produce best practices and provide recommendations for lifecycle management of commonly occurring risks from raw materials. This effort will provide a guideline to facilitate risk assessment process, and build an industry consensus on value-added risk assessment approaches. The plan and current progress will be presented for industry peers’ input and comments.
Janeen Skutnik-Wilkinson -
Chiali Liu, Ph.D. -
Janssen Supply Chain
Duncan Low, Ph.D.,