Autolus Secures Vital MHRA Certification for Nucleus Facility

Autolus Therapeutics, a clinical-stage biopharmaceutical company, has received a GMP certificate and a Manufacturers Importation Authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its Nucleus manufacturing facility. The certification, coming after a full site inspection in February 2024, allows the company to produce commercial and clinical products globally. Chief Technology Officer, Dave Brochu, praised the manufacturing team for their efficient work. The company develops T cell therapies for various diseases and is in the process of seeking approvals for its lead product, obe-cel, an investigative treatment for adult relapsed/refractory B-precursor ALL, which has demonstrated promising results in clinical trials with reduced toxicity and improved persistence. Obe-cel has received critical designations from the FDA and EMA including Orphan Drug, PRIME, and RMAT, solidifying Autolus' position in the immuno-oncology space. The company is keen to continue collaborations with regulatory bodies and their academic partner, UCL, in ongoing clinical evaluations. The press release also provides customary caution regarding forward-looking statements and outlines the company's contact information.