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Thursday, February 17, 2022 9:34:22 AM
announced commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient
This milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility for compassionate use cases
As previously reported, the MHRA license was received in December of 2021, following nearly two years of preparations. This included hiring and training of technical staff, preparation of approximately 1,000 regulatory documents (including Standard Operating Procedure documents and others), validation of facilities, equipment and protocols, and practice manufacturing cycles. This was followed by a review and detailed inspection by the MHRA.
Since the issuance of the MHRA license, Advent Bioservices, NW Bio’s contract manufacturer in the UK, has been conducting the required post-approval re-validations and testing so that the facility is now ready for the manufacture of cell therapy products for clinical use. Accordingly, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility.
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