Granting of a manufacturing licence variation marks the first time a collaborating company has been authorised to start production of clinical material at the CGT Catapult manufacturing centre.
Autolus’ manufacturing operations within the Cell and Gene Therapy (CGT) Catapult manufacturing centre in Stevenage, have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to be part of the CGT Catapult GMP licences, allowing the company to begin manufacturing materials for clinical trial supply from the centre.
The UK-based clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies is the first to be added to the manufacturing centre Investigational Medicinal Products (IMP) licence leveraging the innovative and collaborative development, operating and licensing model, which allows companies at the Stevenage CGT Catapult manufacturing centre to be included in the over-arching licences for the site, which were awarded to CGT Catapult in August 2018.
The Manufacturers Authorisation for IMPs is an EU requirement for the production of material for patient use, in clinical trials. With the awarding of this licence, Autolus will now be able to produce therapies that can progress to clinical trials. The other collaborating companies will also be working with the MHRA to receive a variation of the manufacturing centre licences in the near future.
The positive outcome of the Autolus MHRA inspection demonstrates how our model of providing a fully supported best-in-class infrastructure works and is helping our collaborators receive the licences required for developing these novel therapies.
The variation of our MHRA licences to incorporate Autolus is also a testament to the close engagement CGT Catapult and its collaborators have to accelerate the large-scale delivery of these innovative Advanced Therapies. We look forward to continuing collaboration with all the current and future companies in the manufacturing centre and its surrounding cluster, as they utilise our licences and systems to move towards the production of the first batches of clinical materials, which could ultimately be life-saving treatments for patients.