Helped a clinical-stage allogeneic gamma-delta T-cell therapy developer regain control of quality operations and supplier oversight following organisational restructuring, without compromising compliance or product quality.
Case Studies
Strengthening Quality Operations for an Allogeneic T-Cell Therapy Developer
The Challenge: Restoring Control of a Stretched Quality System
A clinical-stage allogeneic gamma-delta T-cell therapy developer had built its Pharmaceutical Quality System and quality procedures to be resourced by a larger team. Following organisational restructuring, the remaining team could no longer manage those procedures in the same way. Quality actions began falling overdue, and pressure mounted on supplier oversight at a point when maintaining compliance and product quality was critical to the programme.
Our Approach
One of eXmoor Pharma’s Qualified Persons, Drew Hope, was named on the client’s manufacturing authorisation following a focused onboarding process. Drawing on his experience supporting multiple CGT manufacturers, Drew identified where the client’s quality processes could be made more proportionate to the resources actually available to the team. Alongside routine QP duties, he worked directly alongside the client to ease operational bottlenecks and help the team regain control of priority quality activities, without compromising the compliance standards required for clinical manufacturing. As revised Annex 1 requirements came into effect, Drew also developed the facility’s first written Contamination Control Strategy, bringing what had previously been an informal approach into a single documented framework.
Deliverables
The Outcome
Impact
A more risk-based approach to supplier oversight, combined with hands-on audit support, helped the client bring its supplier audit schedule back under control. This freed up quality resources to close outstanding compliance gaps and strengthen the wider Pharmaceutical Quality System, giving the team a sustainable footing to manage quality operations going forward.
“Drew brought experienced, practical QP support exactly when we needed it. He worked closely with our team to simplify key processes, strengthen supplier oversight and restore control of priority quality activities, while maintaining the compliance standards required for clinical manufacturing.”
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