Requirement For Producer Cell Line For GMP Viral Vector Packaging

Location

Description

The Clinical Biotechnology Centre (CBC) has recently validated a GMP-compliant recombinant adeno‑associated viral vector (rAAV) manufacturing platform process to support UK academic clients in transitioning their gene therapy programmes from research into human clinical trials. The work took over four years of intensive effort, including initial process development, iterative process optimisation and scale‑up to ensure suitability for GMP technology transfer. Critical starting and raw materials were selected and approved for use on the platform, as well as determining the optimal process parameters to ensure consistent performance. The validated platform process is now installed within the CBC’s GMP clean room viral vector manufacturing suites. As rAAV manufacturing is inherently complex, technically demanding, and highly sensitive to changes in process conditions, any modification to the validated platform carries considerable risk to the quality of the products being manufactured. Even minor changes could have a significant impact to disrupt platform performance that would require months of expensive re‑optimisation and re‑validation activities, which would present unacceptable operational and business risks.

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CPV Codes

• None found

Legal Justification

CBC’s validated GMP AAV platform being built and validated around VPC2.0 and continuity required to avoid disproportionate re-validation, delay, cost and operational risk. Only Thermo Fisher is able to grant the required rights and support for these specific cell lines, and no reasonable alternative exists without disproportionate consequences.

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