NEWARK, Del., July 15, 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.
The confirmation obtained by ACROBiosystems explicitly states that no human or animal-derived components requiring proof of compliance with biological raw material guidelines are used in the composition and preparation of this material, and the core active ingredient is recombinant human IL-15 protein (0.3 g/L), which fully meets the PMDA’s evaluation requirements in terms of safety.
Suitability Confirmation Certificate for Regenerative Medical Product Materials
As a key cytokine for high-quality immune cell culture and in vitro functional validation, IL-15 plays a crucial role in the preparation of CAR-T, CAR-NK, and TCR-T adoptive cell therapies. The ability of ACROBiosystems’ GMP-grade recombinant human IL-15 protein to pass PMDA certification is attributed to its comprehensive GMP production system, design without animal-derived components, and complete functional validation data. This product can specifically activate downstream JAK-STAT and PI3K-AKT signaling pathways in immune cells, significantly enhancing the cytotoxic activity and in vivo persistence of T cells and natural killer cells, effectively improving anti-tumor immune memory and reducing cell exhaustion. It can also efficiently induce the expansion and enrichment of high-quality cell subpopulations, such as stem cell-like memory T cells (Tscm) and long-lived memory NK cells. From production processes and quality control to functional validation, ACROBiosystems has established a complete regulatory support documentation package, including material compliance evidence, virus testing validation, and stability study data, providing solid support for developers in meeting the application requirements of regulatory agencies like the PMDA.
This certification provides further support for ACROBiosystems to better serve its customers and accelerate the drug development and approval process. On the business front, after receiving the official PMDA confirmation, developers of cell therapies using this IL-15 protein can directly reference this confirmation when applying in Japan, greatly simplifying the evaluation process concerning raw materials and shortening the timeline from research and development to clinical trials. By securing this confirmation from PMDA — a globally respected authority, alongside the FDA and EMA — ACROBiosystems demonstrates its commitment to meeting the highest standards of quality required for biopharmaceutical development. This certification fully verifies that ACROBiosystems’ GMP-grade raw materials meet international advanced standards for quality management systems and application registration documents, thus supporting the accelerated drug application and approval process for cell therapy developers in Japan.
In addition to Japan, ACROBiosystems also possesses complete regulatory support capabilities in major global markets: all of its GMP products undergo DMF filing with the FDA in the United States; in China and Europe, where official agencies have yet to open pathways for GMP raw material filings, the company can still provide comprehensive RSF (Regulatory Support File) documentation to assist customers in their drug applications and approvals worldwide. As of April 2026, the company has assisted nearly 30 clients in China, the United States, and South Korea with multiple applications to CDE, FDA, and KFDA, accumulating rich experience in applications.
Establishing a stringent quality management system to ensure the effective guarantee of product and service quality is a strategic decision for ACROBiosystems Group. Since its establishment, the group has continuously improved its quality management system, aiming to accelerate the development and approval process of biopharmaceuticals. ACROBiosystems Group first obtained ISO 9001 certification in 2016, followed by ISO 13485 certification in 2018, and established a GMP quality management system in 2021. In 2024, its GMP production site in Suzhou received dual ISO 9001 and GMP certification. In 2025, both the Beijing and Suzhou sites received authoritative certification from the RX360 International Pharmaceutical Supply Chain Alliance. The company has an experienced professional quality management team familiar with the biopharmaceutical regulations of different countries and regions, closely follows industry trends, and can rapidly establish or improve quality management systems according to different product types, customer applications, and changing regulatory requirements, thereby facilitating appropriate product development and production to meet diverse customer needs while aligning with regulatory requirements and market conditions. ACROBiosystems is committed to providing partners with the highest quality products and the most comprehensive regulatory support documentation, continuously safeguarding the biopharmaceutical approval process.
About ACROBiosystems Group：
ACROBiosystems Group, founded in 2010 and listed in 2021, is a biotechnology company aimed at being a cornerstone of the global biopharmaceutical and healthcare industries by providing innovative products and business models. The company spans across the globe and maintains offices, R&D centers, and production bases in more than 15 different cities within the United States, Switzerland, the United Kingdom and Germany. ACROBiosystems Group has established numerous long-term and stable partnerships with the world’s top pharmaceutical enterprises, including Pfizer, Novartis, and Johnson & Johnson, and numerous well-known academic institutes. The company comprises several subsidiaries such as ACROBiosystems, bioSeedin, Condense Capital, and ACRODiagnostics.
ACROBiosystems’ brands include Resilient Supply, CytoPak, SAFENSURE, FLAG, Star Staining, Aneuro, ComboX, GENPower and many others. Its main products and services are recombinant proteins, kits, antibodies, scientific services, and other related products. ACROBiosystems employs a strict quality control system for its products that are used in biopharmaceutical research and development, production, and clinical application. This includes targeted discovery and validation, candidate drug screening/optimization, CMC development and pilot production, preclinical research, clinical trials, commercial production, and clinical application of companion diagnostics.
Through the continuous development of new technologies and products, ACROBiosystems Group creates value for the global pharmaceutical industry and actively empowers our partners. The company is dedicated to accelerating the drug development process, including targeted therapies, immunotherapeutic drugs, and their clinical applications, and contributes to global health.
