Case Studies

Optimising AAV8 Manufacturing for Preclinical Success

Improved scalability and purity of AAV8 processes, providing high-quality material and accelerating clients’ path towards successful clinical trials.

The Challenge: Scalable, High-Quality Manufacturing

AAV8 gene therapy developers often face significant hurdles in scaling academic processes for clinical readiness. Challenges include low process yields and complex impurity profiles that, without significant optimisation, can impact the delivery of suitable material for preclinical and toxicology studies, resulting in delays to clinical programs.

Our Approach

Over the past decade, eXmoor Pharma has partnered with multiple clients to deliver AAV8 material generation projects alongside full process and analytical development packages. By maintaining close collaboration throughout, from technology transfer to final deliverables, eXmoor Pharma applied its deep expertise in AAV manufacturing process design to optimise performance and ensure scalability.

Execution

Technology Transfer:

Reviewed existing documentation, conducted reciprocal site visits, and executed baseline processes for sign-off.

Process Development:

Investigated the impact of seeding density on AAV8 upstream yield.

Process Development:

Evaluated alternative lysis reagents to replace Triton X-100.

Process Development:

Designed scalable clarification filter trains and eliminated non-scalable steps from academic processes.

Process Development:

Optimised polishing steps to remove contaminants and empty capsids.

Process Development:

Developed scalable ultrafiltration-diafiltration (UFDF) unit operations.

Material Generation:

Supplied low endotoxin AAV8 material (adherent and suspension-based) for R&D and preclinical studies, including toxicology.

Analytical Development:

Developed rapid AEX-HPLC methods to measure full-to-empty capsid ratios.

Analytical Development:

Optimised qPCR assays for viral titre measurement.

Analytical Development:

Conducted residual analysis of HCP and HCDNA.

The Outcome

Deliverables & Impact

eXmoor Pharma delivered an improved, scalable manufacturing process for AAV8, alongside high-quality materials required for preclinical development.

This enabled clients to progress confidently towards clinical trials with a robust and compliant process.

Download a copy

Case Studies

See how eXmoor Pharma has helped biotech innovators scale their therapies with precision and efficiency.

Enhancing Lentivirus Stability for Clinical Progression

Resolved lentivirus stability challenges, securing regulatory approval and progression into Phase 2 clinical trials for a US biopharma client.

View Case Study

Optimising iPSC Manufacturing for Clinical Success

Transformed academic iPSC processes into GMP-ready clinical manufacturing strategies, overcoming significant scalability and regulatory hurdles for innovative cell therapy development.

View Case Study

Let’s Accelerate Your Therapy Together

Whether you’re in early-stage development or scaling up for commercial production, eXmoor Pharma provides the expertise and flexibility you need. Partner with us to move your therapy forward with confidence.

Request a proposal