Akron Bio Receives Eligibility Confirmation from PMDA in Japan for the Commercialization of Virus Inactivated Human Fibronectin in Clinical Cell Therapy Manufacturing
BOCA RATON, Fla.--(BUSINESS WIRE)--Akron Bio (“Akron”), a leading supplier of critical inputs for cell and gene therapies, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted Akron Eligibility Confirmation for its cGMP Virus Inactivated Human Fibronectin. The PMDA Notification (No. 1205004) indicates that the product – including all raw materials and consumables used in the manufacturing process – complies with requirements for animal and human-derived materials defined in the Japanese Standards for Biological Raw Materials (JSBRM) issued by the Ministry of Health, Labour and Welfare (MHLW) and that none of the product’s components present safety concerns (i.e. toxic substances, deleterious substances, heavy metals, physiologically active substances other than the fibronectin).
Akron's Virus Inactivated Human Fibronectin has been on the market for nearly a decade and is a top choice for facilitating the attachment and proliferation of different anchorage-dependent cells during cell therapy manufacturing. The Eligibility Confirmation is a significant milestone for this product in that it bolsters global regulatory support and provides users with greater assurance regarding the safety and integrity of the material. This filing complements Akron’s existing Type II Drug Master File (DMF) with the FDA.
“Japan is recognized as a global leader in the development and advancement of regenerative medicines. This eligibility confirmation from the Japanese regulatory authorities is another example of Akron products being recognized by regulatory authorities as safe and compliant. Advanced therapies are shaping the future of healthcare worldwide and as more of these life-changing products reach commercialization, innovators continue to rely on Akron Bio to provide safe and effective cGMP materials to support the manufacture and delivery of transformative medicines.” Said Chris Murphy, CEO of Akron Bio.
Akron’s Virus Inactivated Human Fibronectin is manufactured, tested, and released following relevant cGMP guidelines for ancillary materials and is specifically formulated for cell therapy manufacturing applications. This product leverages pharmaceutically licensed, virus and prion-inactivated pooled human plasma sourced from licensed donation centers in the US as a raw material (donor screening and virus testing per 21 CFR 610.40), offering greater batch-to-batch consistency and a unique safety profile.
About Akron Bio
Akron is a leading services provider to the cell and gene therapy industry. Akron leverages more than 100,000 square feet of development and cGMP manufacturing capacity to provide advanced therapy developers the scale, compliance, and regulatory support necessary to drive novel treatments from discovery to commercialization. For more information, please visit www.akronbiotech.com.
Contacts
Bethany Neybert
bneybert@akronbiotech.com
