How supplier stratification governance models de-risked raw material supply to support advancement of BlueRock’s pipeline into the clinic

Abstract

Biotechnology and life science companies interact in a specialized supply chain within a regulated environment. Factors such as cold chain/temperature-controlled logistics, limited shelf life of raw materials (e.g., cell culture media/reagents category), QC testing and QA release criteria are part of regular operations. Additionally, Good x Practice core principles, guidelines, and requirements touch all areas of the organization (i.e., Good Documentation Practice, Good Manufacturing Practice, Good Distribution Practice (GDP), etc.) to ensure drug products and/or medical devices are safe, effective, and high quality for patients