BeijingJune 1, 2026 /PRNewswire/ — Recently, ACROBiosystems’ GMP-grade Human IL-15 protein officially received the “Confirmation of Suitability for Materials Used in Regenerative Medical Products” (Certificate No.: 薬機審長発第47号) from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This is another recognition of ACROBiosystems’ quality system and an authoritative endorsement of its compliance capabilities and professional registration expertise in the core raw materials field for cell and gene therapy.
This confirmation is an official evaluation system established by PMDA for key raw materials used in the preparation of regenerative medical products (such as CAR-T, CAR-NK, TCR-T and other immune cell therapies). Its core function is to allow developers to obtain official confirmation of raw material safety and compliance early in the research and development stage, thereby effectively simplifying the evaluation process for corresponding raw materials when subsequently applying to PMDA for clinical trials or marketing approval, accelerating product development. Obtaining this confirmation requires meeting multiple strict conditions simultaneously: the product and its production process must not contain human or animal-derived components requiring proof of compliance with the “Standards for Biological Raw Materials,” or must provide sufficient compliance evidence; the product must not contain physiologically active substances, toxic substances, heavy metals, or other components that pose direct risks to the safety of clinical trial products; the entire production process must have a comprehensive quality management system, capable of providing complete supply chain traceability and testing verification documentation.
The confirmation obtained by ACROBiosystems this time explicitly states that the material’s composition and preparation process do not use any human or animal-derived components requiring proof of compliance with biological raw material standards, and the core active ingredient is recombinant human IL-15 protein (0.3 g/L), fully meeting PMDA’s evaluation requirements in terms of safety.
As a key cytokine for high-quality immune cell culture and in vitro functional validation, IL-15 plays a critical role in the preparation of adoptive cell therapies such as CAR-T, CAR-NK, and TCR-T. ACROBiosystems’ GMP-grade recombinant human IL-15 protein passed PMDA certification thanks to its full-process GMP production system, animal-derived component-free design, and comprehensive functional validation data. This product can specifically activate the downstream JAK-STAT and PI3K-AKT core signaling pathways in immune cells, significantly enhancing the anti-tumor cytotoxic activity and in vivo persistence of T cells and natural killer cells, effectively improving anti-tumor immune memory capacity and reducing cell exhaustion; it also efficiently induces the expansion and enrichment of high-quality cell subsets such as stem cell-like memory T cells (Tscm) and long-lasting memory NK cells. From production processes and quality control to functional validation, ACROBiosystems has established a complete regulatory support document package, including material compliance certificates, virus testing validation, and stability study data, providing solid assurance for developers to meet regulatory submission requirements from PMDA and other agencies.
ACROBiosystems GMP Human IL-15 Protein Receives PMDA ‘Confirmation of Suitability for Materials Used in Regenerative Medical Products’
This certification provides further support for ACROBiosystems to better serve customers and accelerate the drug development and approval process. From a business perspective, after obtaining PMDA official confirmation, cell therapy developers using this IL-15 protein can directly reference this confirmation when submitting applications in Japan, significantly simplifying the evaluation of raw materials and shortening the product development-to-clinical cycle. From a quality perspective, PMDA, along with the FDA and EMA, is one of the three most authoritative global drug regulatory agencies, known for its scientifically rigorous review standards. This certification fully validates that ACROBiosystems’ GMP-grade raw material quality management system and registration documentation have reached internationally advanced levels, supporting cell therapy developers in accelerating drug submission and approval in Japan.
Beyond Japan, ACROBiosystems also has comprehensive regulatory support capabilities in major global markets: all its GMP products undergo DMF filings with the U.S. FDA; in China and Europe, where official agencies have not yet opened specific filing pathways for GMP raw materials, it can still provide customers with complete RSF (Regulatory Support File) documentation to support drug submissions and approvals worldwide. As of April 2026, the company has assisted nearly 30 customers from China, the United States, South Korea, and other regions in completing multiple submissions to CDE, FDA, and KFDA, accumulating extensive submission experience.
Establishing a strict quality management system to ensure the effective assurance of product and service quality is a strategic decision of ACROBiosystems Group. Since its inception, the Group has continuously improved its quality management system, aiming to accelerate the development and approval of biopharmaceuticals. ACROBiosystems Group first obtained ISO 9001 certification in 2016, ISO 13485 certification in 2018, and established a GMP quality management system in 2021. In 2024, its Suzhou GMP production base obtained dual ISO 9001 and GMP certification. In 2025, both the Beijing and Suzhou bases simultaneously received authoritative certification from the RX360 International Pharmaceutical Supply Chain Consortium. The company has an experienced professional quality management team familiar with biopharmaceutical regulations in different countries and regions worldwide, closely following industry trends. It can quickly establish or improve quality management systems based on different product types, customer application scenarios, and evolving regulatory requirements, carrying out corresponding product development and production to meet diverse customer needs and adapt to regulatory requirements and market environments. ACROBiosystems is committed to providing partners with the highest quality products and the most comprehensive regulatory support documents, continuously safeguarding the drug submission process.
ACROBiosystems Group:
ACROBiosystems Group (Stock Code: 301080) is a multinational biotechnology company founded in 2010, with a vision to become a leading industry platform enterprise providing key biological reagents, solutions, and innovative business models for the global biopharmaceutical and health industry sectors. It was listed on the ChiNext board in 2021. ACROBiosystems Group operates globally, spanning Asia, North America, and Europe, with offices, R&D centers, and production bases in 16 cities across China, the United States, Switzerland, and other countries. To date, it has served over 12,000 customers and established long-term, stable partnerships with globally renowned pharmaceutical companies. The Group’s brands include ACROBiosystems, bioSeedin, Condense Capital, and ACRODiagnostics.
ACROBiosystems adheres to the core brand values of “Quality, Innovation, Service,” dedicated to providing innovative products and solutions to overcome challenges throughout the entire process of biopharmaceutical R&D, production, and clinical application. Main products and services include proteins, antibodies, kits, and analytical testing services, applied in drug screening and optimization, preclinical and clinical trials, drug production processes and process control (CMC), and diagnostic reagent development and optimization for diseases such as cancer, autoimmune diseases, cardiovascular diseases, infectious diseases, and neurological disorders. ACROBiosystems sub-brands include Resilient Supply, Membrane Masterpiece, Star Staining, Aneuro, CytoPak, SAFENSURE, ComboX, ActiveMax, and GENPower.
ACROBiosystems Group is committed to accelerating the R&D and approval of biopharmaceuticals and serving better clinical applications. Through its efforts, it aims to bring value to customers, create value for the entire global market and industry, actively empower partners, accelerate the R&D, approval, and clinical application of various biopharmaceuticals including targeted drugs and immunotherapies, and ultimately contribute to human health.