“Facilities of the Future”, associated with novel therapeutics, flexible suites and single use platforms, are increasingly coming online to serve the next wave of therapeutic products. These facilities help to bridge the gap from lab scale processes into clinical and small-scale commercial manufacturing. Drug manufacturers who seek to mitigate investment risk are leveraging single use systems, closed processes and modular technologies to simplify the design of flexible facilities. While advances in equipment technology have made flexible manufacturing more appealing than ever by reducing the effort to design and validate new processes, the flexible novel therapeutics facility brings its own unique design challenges. Understanding the complexities of novel processes and providing value added flexibility are the primary challenges when designing a facility of the future. The engineering design team is tasked with balancing current needs with the owner’s projected scales and unit operations. Prioritizing product segregation and future-proofing of facility infrastructure add layers of flexibility to the owner but come at risk of project cost and design complexity. Gene and viral therapy processes can also require demanding containment strategies with impacts to both facility infrastructure and operating costs. This presentation will explore these challenges and reference some design cases.
Speaker: Jeffrey Kent | Process Engineer | DPS Group
Jeffrey Kent is a member of the project management team at the DPS Group in Boston, with a proven track record of delivering complex biopharm projects in both process engineering and project management roles. Jeff has a strong background in traditional mAB bioprocesses stemming from roles in manufacturing purification at Biogen Idec and R&D at Genzyme Corp focussing on cell culture. Most recently Jeff has been executing capital design projects for clients seeking flexible platforms for mRNA, viral vectors, gene therapy and cell therapy. Jeff is a Chemical Engineering graduate of Queens University in Canada and holds an M.S. in Chemical Engineering from Northeastern University.
Stacy Price has over twenty years of experience managing organizations and programs for commercial & clinical biotechnology operations. She has been responsible for establishing and leading efforts to direct operations and programs for a variety of functions including: Tech-transfer, facility startup, cGMP and Pilot Manufacturing, Engineering, CMC, process development, IT applications, and supply chain. Prior to working at Ziopharm, Stacy was the Head of Operations in the Process Development organization, at Shire Pharmaceuticals, leading business and laboratory groups through strategic planning & execution. Stacy holds a Master of Science in Biochemical Engineering from Tufts University. She is a Project Management Professional (PMP), has a green belt in Lean Six Sigma and holds a certification in Business Process Management.
Speaker: Katie Shannon |Head of Engineering | Brammer Bio, a part of Thermo Fisher Scientific
Katie Shannon, Head of Engineering at Brammer Bio, a part of Thermo Fisher Scientific, has over 17 years of biopharmaceutical engineering experience spanning new facility construction through commercial manufacturing support. In her current role, she’s responsible for capital portfolio/project management, engineering technical services, global engineering/CQV standards, asset management, real estate, and site services. Katie has successfully overseen the conversion of a protein biologics manufacturing facility to a gene therapy viral vector operation with additional capacity expansion projects in progress. Previously, she held roles at Biogen and Sanofi Pasteur. Katie graduated from Lehigh University with a BS, Chemical Engineering and University of Wisconsin-Madison with an ME, Engineering Management. She’s an active member of the ISPE Women in Pharma Boston Chapter.
Speaker: Michael Paglia |Sr. Vice President, CMC Operations | ElevateBio
Michael has spent his career in biotechnology building, leading, and motivating process development and manufacturing teams to support clinical programs from early development to late stage clinical trials. Michael has been responsible for process development and analytics, cGMP manufacturing operations, CMC regulatory strategy, cellular procurement, and process characterization and validation activities for multiple novel viral, cell and gene therapy products. Currently, Michael is Sr. Vice President of CMC Operations at ElevateBio leading process development, manufacturing and CMC regulatory for a broad portfolio of gene and cell therapy products. Prior to ElevateBio, Michael was the Vice President of CMC operations at Oncorus and bluebird bio as the Sr. Director of Technical Operations and head of Cellular Process Development and Manufacturing Operations.