Complete separation of process and products from each other within a biopharmaceutical manufacturing facility is an operational and regulatory imperative. But does that necessarily mean physical separation? Or can separation be achieved in common space?
I developed a discussion article for the latest electronic supplement to Pharmaceutical Engineering which I hope will stimulate dialogue on concepts and approaches related to facility designs and their impact on segregation strategies required to assure process separation during multiproduct, multiphase manufacturing. Significant pandemic threats, rapid production of Medical Counter Measures (MCMs), and advanced biopharmaceutical business models require rapid development to commercial manufacturing timelines that are only achievable by facilities capable of supporting high-utilization, multiproduct, multiphase manufacturing employing methods and approaches outside previous manufacturing practices. While ISPE’s Baseline Guides present important and useful current best practices, the industry faces many challenges from rapidly evolving technologies, threats, and opportunities.
This article proposes ideas and concepts which I hope will stimulate discussion and debate required to evolve methods and approaches for future Baseline Guides required to meet those challenges. The industry and the patients of the future need your participation in helping the industry quickly and efficiently produce high quality products in the next generation of manufacturing facilities. Please read the article, and then contribute your feedback in the comments section below.