ACROBiosystems Obtains PMDA Material Suitability Confirmation for GMP-grade IL-15, Ensuring Reliable Quality and Strengthening the Biopharmaceutical Approval Process

NEWARK, Del., July 14, 2026 /PRNewswire/ -- Recently, ACROBiosystems has officially received the "Material Suitability Confirmation for Regenerative Medicine Products" (Certificate No.: 薬機審長発第47号) from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for its GMP-grade Human IL-15 protein. This recognition further validates ACROBiosystems' quality system and serves as an authoritative endorsement of its compliance capabilities and expertise in the core raw materials field of cell and gene therapy.

The confirmation is part of an official evaluation system established by the PMDA for key raw materials used in the production of regenerative medical products, such as CAR-T, CAR-NK, and TCR-T immunotherapy. Its core function is to enable developers to obtain official confirmation of the safety and compliance of raw materials early in the research and development process, thereby streamlining the evaluation of these materials when applying for clinical trials or marketing approvals from the PMDA, thus accelerating product development. To obtain this confirmation, several stringent conditions must be met: the product and its manufacturing process must not contain human or animal-derived components that require proof of compliance with the "Guidelines for Biological Raw Materials," or must provide sufficient compliance evidence; the product must not contain physiological active substances, toxic substances, heavy metals, or other components that pose direct risks to the safety of clinical trial products; and the entire production process must have a sound quality management system in place to provide complete supply chain traceability and testing validation data.

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