Successful Scale Up of a High Yielding Viral Vector Suspension Platform to 500 L

12th July 2022 | 10:00am EST / 7:00am PST / 3:00pm BST / 4:00pm CEST | John Ketz, Process Development Senior Scientist, Andelyn Biosciences, Denis Kole, Director - AcceleratorSM Processes Development Services, Pall Corporation and Benben Song, Product Manager Services, Pall Corporation |WATCH FOR FREE

As gene therapies move toward commercialization, the journey to manufacture a high-quality product while achieving economies of scale and reducing facility footprint, can be challenging. Developing and optimizing your process development early on is critical for your company’s long-term success.
In this webinar, we will present our scalable integrated platforms for viral vector production in both adherent and suspension cell cultures. Key factors to consider in choosing the right technology for scaling up will be discussed in terms of factors such as cost, time, and risk. You will hear from Andelyn’s process development team and Pall’s Accelerator℠ process development experts on their strategy, proven methods, and bioprocess solutions, and on how they scaled up an Adeno-Associated Virus (AAV) manufacturing process using FectoVIR®-AAV transfection reagent to up to 500 L.
Attendees will learn how to:

  • Achieve versatility with a scalable, single-use end-to-end platform
  • Optimize small-scale expression systems into a scalable process
  • Achieve goals faster and better with Pall process development team

Presented by John Ketz, Process Development Senior Scientist, Andelyn Biosciences

John Ketz is a Senior Scientist in the Process Development group at Andelyn Biosciences. For the past 5 years he has been the lead scientist for the upstream and downstream development of the suspension platform for AAV production, and its scale up from flask to large bioreactors. Prior to joining Andelyn his research involved investigations into kidney diseases using mouse as a model system. He obtained his Master of Science degree in Biochemistry and Animal Physiology, and Bachelor of Science degree in Biochemistry from West Virginia University.
Andelyn Biosciences

Andelyn Biosciences is a biopharmaceutical CDMO Pioneering Solutions That Turn Hope into Reality™. With 20+ years of experience manufacturing viral vectors, Andelyn’s scientific expertise for development and characterization has led to GMP material being produced for over 75+ worldwide clinical trials and 400+ cGMP clinical batches. Advanced quality systems, full regulatory support, and supply chain vertical integration help accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients.
Followed by Denis Kole, Director – AcceleratorSM Processes Development Services, Pall Corporation

Denis holds a Bachelor of Arts in Biology from Clark University and a 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. Denis spent 9 years in the biotech field holding several positions at large pharma and 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. Denis has held several positions within Pall. Prior to joining PDS he led the field applications team in the US, supporting the adaptation of continuous bioprocessing and process intensification solutions at customer sites.
Benben Song, Product Manager Services, Pall Corporation

Dr Benben Song is globally responsible for product management of Accelerator℠ Process Development Services, Accelerator℠ Validation Services, Regulatory Portal and Training Services. Benben joined Pall in 2015 and has held multiple roles in leading the extractables and leachables validation studies on Pall products, to ensure compliance with the latest regulations and evolving expectations of drug safety. Prior to joining Pall, she managed government contracts on drug cardiotoxicity evaluation at the Stanford Research Institute. Benben holds a PhD in Biochemistry from Stony Brook University and has over 10 years of experience in biotech. She has published over 18 articles in scientific journals and has been invited to present her work at many conferences. When not at work, Benben likes to spend time reading, hiking, and participating in outdoor activities.
Pall Corporation

Pall Corporation provides critical filtration, separation and purification solutions to meet the demanding needs of a broad spectrum of life sciences and industrial customers around the globe.
Across 80 locations and 10,000 people worldwide, we are unified by a singular drive: to solve our customers’ biggest fluid management challenges. And in doing so advance health, safety and environmentally responsible technologies.

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