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. The three-staged model creates a progressive method to enhance the compliance and quality of ancillary materials used for manufacturing.
It will also contribute to the management of high cost of goods in ancillary material manufacturing, where the major contributor to these costs stem from quality assurance and manufacturing requirements.
Several independent frameworks currently exist to manage the quality of ancillary materials. These frameworks are guidelines and have no official regulatory oversight, some of which are appropriate 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 these existing frameworks include a Technical ISO Document that was led by the Standard Coordinated Body (SCB) with the participation of Japan, UK, Germany and the US, among others, as well as the guidance set forth in the USP Chapter <1043>.
This proposed staged regulatory approach supports the harmonization of requirements for GMP production of ancillary materials for drug developers and manufacturers. The paper has been published in Cytotherapy entitled ‘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. This has led to a spectrum of interpretations resulting in inconsistencies in product quality and process qualifications.
Since ATMP final products cannot be sterilized, ancillary material guidelines need to evolve for the safety of patients, and we are committed to leading this effort. The framework proposed could balance interests concerning risk, safety, quality, efficacy, and cost of goods.”
Claudia Zylberberg, CEO, Akron Biotechnology