Case studies: Successful scale-up of upstream viral vector processes using adherent and suspension platforms

Cell and gene therapies have emerged as promising treatments for previously untreatable diseases, and viral vectors are currently the preferred gene-delivery vehicle for most cell and gene therapies. For this reason, safe, robust, and cost-effective manufacturing processes are necessary to support the demands of the patient population. However, complexity around developing and scaling viral vector processes to commercial manufacturing scale, and the lack of standardized approaches, remain as challenges that can impact therapy development timelines and productivity. Selection of the appropriate production platform plays a key role in the successful implementation of a process that meets the commercialization timelines and manufacturing costs. 

During this webinar, we will share two case studies that demonstrate successful scale-up for viral vectors, leveraging Pall’s platform, process expertise, and platform knowledge to help accelerate the development timelines. 

• The first details the process development and scale-up for a Helper-Dependent-Adenovirus (HDAd) using adherent culture and the iCELLis^® bioreactor platform
• Secondly, Andelyn Biosciences, a contract manufacturing organization, presents on the development of a highly productive Adeno Associated Virus (AAV) suspension process and how they worked with Pall’s Process Development Services to scale-up to 500 L and 1000 L scale, using the Allegro™ STR bioreactor platform

Samir Acharya

Associate Director of Process Development, Andelyn Biosciences

Denis Kole

Director, Accelerator Process Development Services (PDS), Pall Corporation