Evaluation and performance of an AAV affinity resin: a CDMO case study

The success and growing pipeline of AAV-based gene therapies highlights the immense value and potential of this technology in addressing unmet medical needs. This has increased the demand for the development of efficient and robust downstream purification processes, which is crucial to ensure the production of high-quality AAV vectors for clinical applications. Particularly important is the performance of the affinity capture step of AAV as a scalable unit operation to delivery of high purity and recovery.

In this presentation, Pharmaron, a leading CRO/CDMO, investigates the enhanced capabilities of the Thermo Scientific™ POROS™ CaptureSelect™ AAVX Affinity resin for AAV capture. Their development of an efficient, cost-effective platform process to purify various serotypes of AAV hinged primarily on high recovery and high purity of AAV capture. This presentation covers Pharmaron’s early development work on optimizing the POROS CaptureSelect AAVX resin recovery by integrating high-throughput POROS AAVX Robocolumns experimentation with the design of experiments (DoE) approach.

It includes small scale data to estimate dynamic binding capacity using POROS AAVX prepacked columns and POROS AAVX manually packed column data to verify resin performance at scale.

• Overview of downstream platform for AAV purification
• Pharmaron Gene Therapy’s methodology for exploring POROS CaptureSelect AAVX affinity resin enhanced capabilities
• Performance of POROS CaptureSelect AAVX resin in terms of dynamic binding capacity, recovery, and impurity clearance at small and large scale

For Research Use or Further Manufacturing. Not for diagnostic use or direct administration in humans or animals.

Buzz Lobbezoo

Field Application Scientist at Thermo Fisher Scientific

Buzz Lobbezoo is a Senior Field Applications Scientist at Thermo Fisher Scientific supporting the CaptureSelect and POROS resin for Bioproduction group in EMEA North. Holds a degree (hons.) from the University of Kent at Canterbury. Has over 25 years’ experience in downstream processing, working for various small and medium sized biotech companies as well as the University of Cambridge. Throughout his career, he has worked on every aspect of downstream processing, working with a full gamut of techniques for the purification of a range of biomolecules.

Spyridon Gerontas

Senior Technical Specialist, Process Sciences at Pharmaron

Spyros Gerontas is a Senior Technical Specialist in Process Sciences at Pharmaron Gene Therapy, Liverpool. He has over 15 years’ experience in developing downstream processing (DSP) platforms and performing process modelling/economic analysis for biopharmaceuticals. In his role, he leads the bioprocessing development of gene therapy products in Pharmaron’s cutting-edge facilities. Furthermore, he promotes the implementation of innovative technologies in gene therapy downstream processing through strategic technology partnerships in order that Pharmaron gains/maintains a competitive edge. Moreover, he leads the scale-up and technology transfer of DSP platforms for viral vectors and recombinant proteins to Pharmaron’s strategic partners. Spyros holds a PhD in Biochemical Engineering from University College London (UCL).

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SPEAKERS

Buzz Lobbezoo

Field Application Scientist at Thermo Fisher Scientific

Spyridon Gerontas

Senior Technical Specialist, Process Sciences at Pharmaron

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