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

Tuesday 08:00 PDT / 11:00 EDT / 15:00 GMT / 16:00 CET

Sponsor

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

Dr. Samir Acharya, Associate Director of Process Development is responsible for Process and Platform Development, their optimization, characterization and technology transfer. Prior to Andelyn Biosciences, he has over 25 years of research experience in mechanisms of genomic instability and pathways of cell survival and proliferation. He has authored numerous peer-reviewed scientific publications and book chapters, received national grants and participated in all aspects of academic education including mentoring, teaching and evaluation. His expertise is in the fields of biochemistry, molecular & cell biology and cancer. He has extensive experience in assay and method development utilizing tools involving molecular & cell biology, molecular genetics, microbiology, microscopy, protein purification, biochemical/biophysical analyses and enzyme kinetics. Dr. Acharya has a Bachelor’s degree (B.Sc.) in Chemistry from St. Stephen’s College, University of Delhi; Master’s degree (M.Sc.) in Biotechnology from Jawaharlal Nehru University, and a doctorate (Ph.D.) degree in Biochemistry from Indian institute of Science, Bangalore, India.

Denis Kole

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

Denis received his undergraduate degree in Biology from Clark University and his PhD from Worcester Polytechnic Institute in Massachusetts, where he studied stem cell biology and cellular reprogramming. Denis spent two years as a post-doctoral researcher studying cellular microenvironments and 3D tissue engineering of skeletal muscle tissue models. Prior to joining Pall, Denis spent 9 years in the biotech field holding several positions at large pharma and Contract Research Organizations (CROs), supporting upstream and downstream processes for early discovery programs. He joined Pall in 2017 and currently leads the Process Development Services (PDS) team in Westborough MA. Prior to leading the PDS team Denis led the US technical field applications team supporting the adaptation of continuous bioprocessing and bioprocess intensification solutions.