BOCA RATON, Fla., Jan. 22, 2020 /PRNewswire/ -- Akron Biotechnology, a leading supplier of ancillary materials to the regenerative medicine industry, today announces the publication of a white paper proposing a new pragmatic, unified and staged approach for the qualification of ancillary materials for the manufacture of Advanced Therapy Medicinal Products (ATMPs).

The proposed approach aims to meet the needs of both regulators and ATMP developers. Thethree-stagedmodel createsa progressive method to enhance the compliance and quality of ancillary materials used for manufacturing. It will also contribute to the management ofhigh cost of goodsin ancillary material manufacturing,where themajor contributor to these costs stem from quality assurance and manufacturingrequirements.

Several independentframeworks currently exist to manage quality of ancillary materials. These frameworks are guidelines and have no official regulatory oversight, some of which areappropriate for use in the ATMP market.Nonetheless, they are widely adopted by the industry, resulting in ancillary materials that are manufactured according to different interpretations of 'manufactured under GMP'. Examples of theseexisting frameworksincludea Technical ISO Documentthat was ledby the Standard Coordinated Body (SCB) with the participation of Japan, UK, Germany and US, among others, as well as the guidance set forth in USP Chapter <1043>.

This proposed staged regulatory approach supportsthe harmonizationof requirements for GMP production of ancillary materialsfor drug developersand manufacturers. The paper hasbeenpublished in Cytotherapyentitled 'Towards a common framework for defining ancillary material quality across the development spectrum'. Akron CEO, Dr. Claudia Zylberberg, one of the authors and the main driver behind this framework, believes that this approach will be welcomed by the broad community as it harmonizes and clarifies the Quality requirements for both ATMP developers and ancillary material manufacturers.

"The regulations around the development, efficacy and manufacture of the current generation of ATMPs are tightly controlled. However, regulatory harmonization around ancillary materials, the building blocks of ATMPs, is needed," said Claudia Zylberberg, CEO, Akron Biotechnology. "This has ledto a spectrum of interpretations resulting in inconsistencies in product quality and process qualifications.Since ATMP final productscannot be sterilized, ancillary materialguidelines need to evolve for the safety of patients, and we are committed to leadingthis effort. The framework proposed could balance interests concerning risk, safety, quality, efficacy, and cost of goods."

About Akron BiotechnologyAkron Biotechnology is a leading supplier to the regenerative medicine industry. Akron develops and manufactures cGMP-compliant ancillary materials and provides specialized services in order to accelerate the clinical development and commercialization of advanced therapies. For more information, please visit us atwww.akronbiotech.com.

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SOURCE Akron Biotechnology

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Akron Biotechnology publishes industry-wide recommendations for ATMP ancillary material regulation - P&T Community