Consulting
Process Development
Analytical Services
GMP Manufacturing
Facility Design & Process EngineeringTransformed academic iPSC processes into GMP-ready clinical manufacturing strategies, overcoming significant scalability and regulatory hurdles for innovative cell therapy development.
Case Studies
Optimising iPSC Manufacturing for Clinical Success
The Challenge: Overcoming Scalability and Regulatory Hurdle
An innovative cell therapy start-up required a feasibility study to translate its iPSC-based academic process into a GMP-ready clinical manufacturing strategy. Several non-translatable unit operations and an extended culture period posed significant scalability and regulatory hurdles. The client needed a cost-effective, efficient approach to ensure feasibility while maintaining product quality.
Our Approach
eXmoor Pharma worked closely with the client to assess and refine the process for GMP readiness, ensuring seamless technology transfer, process optimisation, and scalability:
Execution
The Outcome
Deliverables & Impact
- Road map for future technology transfer.
- Assessment and feasibility reports on key unit operations.
- Comparability studies between research and GMP materials.
- Next-step process development and CMC strategy.
eXmoor Pharma provided a clear pathway to GMP manufacturing, ensuring process scalability and regulatory alignment. Product quality and yield were optimised, demonstrating the impact of a collaborative approach between the client’s process expertise and eXmoor Pharma’s development capabilities.
Case Studies
See how eXmoor Pharma has helped biotech innovators scale their therapies with precision and efficiency.
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.
Streamlining AAV Manufacturing for Clinical Scale-Up
Achieved GMP compliance through advanced optimisation, significantly enhancing yield and accelerating clinical readiness for a European biotech client’s AAV gene therapy.
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.