- AGC Biologics’ Milan site reached its tenth regulatory approval from either the EMA or FDA, supporting the EU authorisation of AUCATZYL®.
- The site manufactures lentiviral vectors for Autolus Therapeutics’ CAR-T therapy to treat r/r B-ALL in adult patients.
AGC Biologics has announced that its Milan Cell and Gene Center of Excellence has reached its tenth product approval from either the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA), following the European Commission’s authorisation of AUCATZYL® (obecabtagene autoleucel – obe-cel) on 21 July.
AUCATZYL®, developed by Autolus Therapeutics, is now approved in all 27 European Union member states to treat adults aged 26 and over with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (r/r B-ALL). This EU approval follows regulatory clearances in the United States in November 2024 and the United Kingdom in April 2025.
AGC Biologics’ Milan facility, a CDMO with a 30-year history, has supplied the lentiviral vector used in the therapy since partnering with Autolus in 2020. “This European approval for Autolus is a milestone we are thrilled to be part of,” said Alberto Santagostino, CEO and President, AGC Biologics. “By ensuring a reliable supply of their vital lentiviral vector, we empower our partners to focus on patients.”
The Milan site has played a key role in clinical and commercial-scale contract manufacturing for complex cell and gene therapies. According to Luca Alberici, General Manager of the Milan facility, the collaboration with Autolus reflects “a model of true partnership” that meets the demands of global manufacturing.
To date, the AGC Biologics Milan team has supported numerous products from clinical development to market authorisation, manufacturing hundreds of clinical batches and adhering to global regulatory standards and technical transfer requirements.
