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

 

Speakers

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.

 

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.