Biomanufacturing: A case study from facility design to 1st batch of GMP manufacturing, a successful case from 0 to 1 transition

Abstract

Executive summary: As the global big landscape affecting the global pharmaceutical industry, the cost of building a cGMP biologics facility worldwide has increased drastically. It is critical to do the right things from facility design, built out, equipment procurement, commissioning, qualification, facility release to GMP manufacturing in order to avoid unexpected events occurring impacting delivery of the finished project on time. The speaker is going to share his experience on how to manage such a complex project smoothly achieving from 0 to 1 transition.