Autolus Therapeutics receives MHRA certification for Nucleus site

Autolus Therapeutics announces that following the most recent GMP inspection by the MHRA in February 2024, Autolus’ Nucleus manufacturing facility in Stevenage has obtained a Manufacturer’s Importation Authorisation together with the accompanying GMP certificate. This authorisation enables Autolus to manufacture for global commercial and clinical product supply from the Nucleus effective as of March 18, 2024. Following a full site inspection in February 2024, Autolus’s Nucleus site has recently received the formal certification from the MHRA. The MHRA issued two new licenses to cover both clinical and commercial manufacture from the site and found no major or critical observations in their summary report.