Optimizing the Biomanufacturing Enterprise
Jeffrey Odum, Qualified Instructor with ISPE, has authored the following article, “Optimizing the Biomanufacturing Enterprise,” for European Pharmaceutical Review. The article, which appears in European Pharmaceutical Review Issue 3 in print and online, outlines three primary considerations for biopharmaceutical facility design: product attributes, process attributes, and facility attributes.
Odum starts the article by sharing, “The recognition and establishment of manufacturing as an enterprise model is important. To achieve the good manufacturing practice (GMP) goals of establishing control, providing proof of control, and ensuring a means of validating a return to the controlled state in the event of a problem, effective design solutions for the process, facility and infrastructure elements of the manufacturing enterprise must be defined early in the project lifecycle. These elements should be integrated with each other to support the robust target for manufacturing. This could mean defining trade-offs early in the conceptual design process between each of these elements.” He goes on to note, “The three elements of the enterprise must be integrated, the unit operations defined, and the facility attributes coordinated to support a well-defined segregation strategy and operational approach.”
Read full article
Note: Readers must subscribe to the online edition to view the full article.
Professional Development Opportunities with ISPE
Upcoming training courses led by Jeffrey Odum are as follows:
- Biopharmaceuticals: C> and ATMP, 8-9 October 2024
- Biopharmaceuticals: CMC Aspects, 5-8 November 2024
- Overview: Biopharmaceutical Manufacturing Processes, 18-21 November 2024
- GMP Sterile Drug Manufacturing Facility, 3-6 December 2024
- ATMP Manufacturing, 10-13 December 2024
Learn more about professional development opportunities.
About European Pharmaceutical Review
European Pharmaceutical Review is a resource for scientists working in late-stage drug development, scaling, and manufacturing. It provides professionals in the pharmaceutical and life science community with the latest insights on regulations, research findings, developments, and cutting-edge technological advancements.