RAAV Purification For High Cell Density Processes

Pharmaron scientific poster on optimising rAAV purification for intensified high cell density processes

Poster Authors:

Franco Gonzalez¹,T Patterson¹, L Winstanley¹, B Adamiak¹,M Munye², J Guenat³, J Harvey³, D Bamiwuye³, O Li³, HY Li³, R Matos³, PK Ogoe³, D Marginean³, M Barreira³, P Young¹

¹Pharmaron Biologics, Liverpool, UK

²Complement Therapeutics, London, UK

³Cell and Gene Therapy Catapult, London, UK

rAAV Purification

rAAV purification remains one of the most challenging parts of producing gene therapy materials. As upstream methods shift towards higher cell densities and perfusion-based bioreactors, downstream teams must manage a much heavier impurity load while still protecting product quality and maintaining strong viral particle (VP) yields.

This poster was presented at Bioprocessing Summit Europe hosted in Barcelona (March 2026), as part of an Innovate UK collaboration between Pharmaron, Complement Therapeutics, and Cell and Gene Therapy Catapult, showing a purification strategy that was developed to support intensified high cell density Recombinant Adeno-Associated Virus (rAAV) production.

Capabilities

Knowledge Center

Biologics and Cell & Gene Therapy

Protein Science

Biologics CDMO

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Using Pharmaron’s rAAV Downstream (DSP) platform and perfusion mimic models, purification steps, including clarification, TFF, and affinity chromatography, were optimized to address increased impurity loads while preserving product quality. Initial work used a reference gene, with final testing planned on a clinically relevant target.

Feasibility studies showed Pharmaron’s AAV platform effectively handled increased impurities from a 10x cell concentrated rAAV upstream perfusion mimic. Downstream steps – clarification, TFF, and affinity chromatography – were further optimized to improve yield and product quality.

Pharmaron Optimizations

Clarification – to maximize impurity removal and throughput
Tangential Flow Filtration – to further concentrate and remove impurities
Affinity DoE – to optimize affinity step, maximizing rAAV recovery and minimizing impurity removal

Platform Readiness

This collaborative project established a scalable, robust rAAV production platform, achieving a key step toward developing intensified, high-cell-density processes that addressed productivity limitations in current rAAV manufacturing.

References:

FDA — Cellular and Gene Therapy Products— Regulatory authority for AAV-based gene therapies; supports compliance framing
Innovate UK — Funding body for the collaborative project; adds credibility and context
Cell and Gene Therapy Catapult — Named project collaborator; authoritative UK CGT body
EMA — Advanced Therapy Medicinal Products — European regulatory context for AAV gene therapies

Get a Copy of This Poster

Download this full poster. It includes clarification data, TFF results, DoE model outputs and affinity confirmation run data.