Consulting
Process Development
Analytical Services
GMP Manufacturing
Facility Design & Process EngineeringResolved lentivirus stability challenges, securing regulatory approval and progression into Phase 2 clinical trials for a US biopharma client.
Case Studies
Enhancing Lentivirus Stability for Clinical Progression
The Challenge: Addressing Drug Substance Stability Concerns
A US biopharma client, developing a cell-based therapy using a lentiviral platform in clinical Phase 1, faced significant challenges with drug substance stability, threatening the progression of their therapy to Phase 2.
Our Approach
Our team successfully transferred the client’s existing process to our development laboratory, screened drug substance formulations, improved GMP fill-finish processes, and generated robust stability data through live and accelerated studies to define shelf-life.
Deliverables
The Outcome
Impact
The validated formulation and stability data enabled confident progression into Phase 2 clinical trials, ensuring regulatory compliance and significantly enhancing the therapy’s commercial viability.
Case Studies
See how eXmoor Pharma has helped biotech innovators scale their therapies with precision and efficiency.
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.
Supporting Commercial Scale-up and Technology Transfer
Delivered strategic project management and seamless technology transfer, empowering TxCell’s commercial manufacturing scalability and operational success.
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.