AAV vectors in a spin: zonal ultracentrifugation as an effective, automated and scalable downstream processing methodology

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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AAV vectors in a spin: zonal ultracentrifugation as an effective, automated and scalable downstream processing methodology

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

The commercial manufacturing of vector-based gene therapies and vaccines requires large scale solutions. Density gradient ultracentrifugation, despite its proven capability at research scale, is often presented as non-scalable. However, from seasonal influenza to COVID vaccines continuous flow zonal ultracentrifuges have been utilized to isolate viral particles and vectors using density gradients for over sixty years in commercial production sites globally.

With a wide range of options to choose from, selecting the best vector, the proper gradient, and the most robust system for purification are just a few of the many challenges researchers face during discovery of unique therapies. Once these factors are determined, how to scale from the originally developed process to production quantities becomes yet another challenge.

With the application of adeno-associated virus (AAV) vectors as the main construct used in gene therapies, commercialization has shown to be challenging at the large scale. Developing a cost-effective means of establishing vector purity while ensuring capsid enrichment for commercial scale production is perhaps the greatest test.

As AAV vector gene therapies demonstrate their utility, ultracentrifugation is proving to be a serotype-independent, purification technique. Continuous flow ultracentrifugation provides a robust and viable downstream processing method to separate density dependent full from partially-filled and empty vector capsids.

During this webcast we will explain just how continuous flow ultracentrifugation works, demonstrate how these systems can be effectively implemented in Phase I development of AAV gene therapies, and dispel the myth that scalability to cGMP manufacturing is not possible.

Zonal ultracentrifugation – batch and continuous flow, how it works, effective at all scales
Fast track to commercialization with linear scalability
Density gradient, serotype-independent, separation technique
Eliminate manual operation and standardize with cGMP automated systems
Assistance with challenges of method development

Sandra Meriño

Global Project Director at Alfa Wassermann

Sandra Merino is the Ultracentrifuge Process Specialist and Director of Strategic Solutions at Alfa Wassermann. Sandra has over 20 years of experience working with Ultracentrifugation in industrial applications for Vaccine and Viral vector purifications in vaccine manufacture facilities globally.

Sandra Joined Alfa Wassermann in 2000 from Chiron Vaccines in the UK where she worked on Technology Transfer and Downstream Purification Process Development of recombinant Hepatitis B and C vaccines. This included developing scale-up downstream processing methods using Ultracentrifugation, Chromatography and Ultrafiltration.

At Alfa Wassermann Sandra has been involved in numerous installation projects globally for viral vaccines and viral vectors coordinating the Installation Validation process and customer training. Sandra has co-authored a range of ultracentrifugation patents and publications relating to scale Ultracentrifuge technology and the application to AAV purification.

Seth Brittle

Process Engineer at Alfa Wassermann

Dr. Seth Brittle is a Process Engineer at Alfa Wassermann Separation Technologies where he focuses on connecting sales and marketing activities with the engineering and manufacturing teams. This involves assisting customers in evaluating Alfa Wassermann’s unique technology, scaling their production to commercialization, and automating their processes for GMP. He works closely with new and potential customers developing novel methodologies, performing validation testing, and offering process support. In this role, he also manages the Process and Product Development (PPD) laboratory at Alfa Wassermann’s US headquarters in New Jersey. In this space, research experiments are conducted and prototype equipment are developed, tested and validated. This lab is also where he can conduct equipment and process demonstrations for new and existing clients. Previously, he has worked as a hydrogeochemist performing large-scale analytics on anthropogenic freshwater pollutants. Before that, he worked for the Air Force Institute of Technology as postdoctoral researcher developing radiation detection schemes to characterize and access high-performance polymeric nanocomposites. Seth has an extensive background in a variety of sciences, including: chemistry, nanotechnology, and pharmacology. This diversity has made him knowledgeable and experienced in many purification bioprocesses such as tangential filtration, chromatography, and centrifugation.