Autolus Therapeutics receives Medicines and Healthcare products Regulatory Agency (MHRA) certification for Nucleus commercial manufacturing site [Yahoo! Finance]

Autolus Therapeutics plc - American Depositary Shares (AUTL)

Last autolus therapeutics plc - american depositary shares earnings: 11/7 07:06 am Check Earnings Report

US:NASDAQ Investor Relations: autolus.com/investor-relations

programmed T cell therapies, today 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 (MIA) 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. “We are really proud of our brand-new facility for autologous cell therapies. Our manufacturing team did an outstanding job qualifying, validating and taking into operation the Nucleus in record time and establishing the foundation for high quality product sup Show less Read more

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5/17/24 - Miss

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5/17/24 - Needham & Company LLC
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5/21/24 - Form SC
5/17/24 - Form 10-Q
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Autolus Therapeutics receives Medicines and Healthcare products Regulatory Agency (MHRA) certification for Nucleus commercial manufacturing site [Yahoo! Finance]

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