HPA Case Study: Technical Support for FDA Licensure of Erwinaze™

19 December 2011 by Health Protection Agency

The Process & Analytical Development Group (PADG) provided major technical expertise to support the submission of a biologics license application (BLA) for US licensure of Erwinaze™, a biotherapeutic used for the treatment of acute lymphoblastic leukemia (ALL). This product is manufactured by the HPA in its cGMP facilities at Porton Down and is currently distributed to over 50 countries worldwide by EUSA Pharma. FDA licensure, obtained in November 2011, has greatly improved the availability of this life-saving drug in the US.

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