Design for an Unknown Future: Adaptable ATMP Facilities
1:30 PM – 2:30 PM |
Advanced Therapy Medicinal Products are being rapidly developed and manufactured to treat and cure conditions and diseases with limited or no therapy options. While these breakthrough treatments hold tremendous benefits, their manufacturing processes are novel and may evolve. Improvements in automation, process closure, cell lines, manufacturing technologies, amongst other developments may affect manufacturing facility requirements. Additionally, the commercialization and scale up of these therapies presents significant risk and challenges. This presentation will explore facility designs that meet current manufacturing requirements and are adaptable to future manufacturing needs. Several modalities are considered for the primary design and future operation, including: adherent cell culture, suspension cell culture, autologous therapies, allogenic therapies and viral vector production. We will explore how changes in ATMP production may affect the facility of the future.
Speaker: Howard Sneider | Lead Process Engineer | Nitto Denko Avecia Inc.
Howard is a lead process engineer with Nitto Denko Avecia located in Milford, Massachusetts. He has over 20 years of experience in all phases of process design, process modeling simulations, equipment design specification and selection. Howard has also directed and conducted acceptance testing, start-up, commissioning, and validation and the design of biological, vaccine and API manufacturing processes, clean utilities and similar facilities. His experience includes greenfield and renovation projects at the lab, pilot, and commercial scale. He holds a Bachelor of Science from Columbia University and a Master of Science from the University of Connecticut. Howard is also an accredited CPIP.