The rising tide of venture capital investments in Oregon’s biotechnology sectors – especially startups – foreshadow an uptick in facility investments in the near term. When it comes time to ramp up and manufacture innovations derived from breakthrough research, experienced advice can help new projects avoid old pitfalls. In this three-part series, experts from CAI share observations relevant to today’s manufacturing environment. CAI specializes in supporting quality-critical manufacturing (Good Manufacturing Practice related) or mission-critical facilities in the bioscience, pharmaceutical and medical device applications, among others.
Need to Speed is the name of the game when building a facility to manufacture ATMP products. With a heavy focus on an accelerated schedule and getting your product faster to market this brings unique risks. Converting some project risk factors into success factors could change your whole dynamic and lead to a effective facility start-up. First, there does not need to be a trade-off between cost, schedule, and quality, if your team understands how to deliver quality right first. There are five (5) risks to a facility start up project.
Panelist: Joseph Micsko. Global Director, PMT, CAI
Joe leads CAI’s Process Manufacturing Technology business area and is an Engineering SME. He oversees various projects for Biotech/Pharma clients. He has a wealth of knowledge and experience with over sixteen (16) years in the Pharma/Biotech Industry especially in Single Use Technology (SUT) and Cell and Gene Therapy (C>) Startups. Joseph manages the development and implementation of process improvements designed to achieve greater efficiency in overall Business Operations. He is a subject matter expert in CIP systems, Chemical Distribution Skids, Upstream and Downstream Processing, Single use systems, Autoclaves and Steam-in-Place (SIP). He has extensive knowledge of planning, coordinating, and executing Cleaning Validation Programs to verify compliance and absence of cross-contamination. Joseph has experience with Quality Risk Management (QRM) specifically in process risk and control strategies. He has successfully managed and led diverse teams across the globe delivering numerous Pharma/Biotech projects.