Raw materials have been, and will continue to be, at the core of new sets of therapies coming out over the next decade. Why? Simply because they are either scarce or limited, such as off-the-clot AB serum, or because they encompass a high risk, which is the case for animal-derived components. For this type of materials, concerns with traceability and viral inactivation steps (high risk areas) are often raised, as well as costs associated with quality/regulatory compliance for materials that have only been used as research grade components previously.
Until recently, the lack of standardization and even harmonization in the nomenclature make it difficult to achieve a common understanding of how to handle relevant information with the goal of achieving successful commercialization and approval of these therapeutic options. Many efforts have been in place to understand the diverse portfolio of materials embedded in the manufacturing of cell/gene therapies. Over the last five-plus years, white papers and glossaries have been published by many experts. Furthermore, USP created a Chapter <1043> that covers many ancillary materials and several aspects unrelated to compliance in the ex vivo manufacturing setting. These ancillary materials are for further manufacturing use (the ultimate intended use) and not the finished release product. The Standard Coordinating Body (https://www.standardscoordinatingbody.org/, SBC ) is organized as a non-profit [501(c)3] consortium that operates through public-private partnerships with government agencies, regulatory bodies, and other government organizations involved in establishing consensus standards for regenerative medicine and other advanced therapy products. The SCB, in close relationship with National Institute of Standards and Technology (https://www.nist.gov) are combining efforts to generate standards, such as ancillary materials (AM), cell counting, bioprocessing and transportation/logistics, among others.
The AMS (which is the correct term for all these components), have an ample spectrum, from biologics and biochemicals to small molecules. The complexity of each individual party is addressed in a new upcoming technical document. Led by US, Japan, and UK experts, a 3-part Technical Specification (TS) document on ancillary materials (AM) is on its way to be published by the International Standards Organization (ISO) Biotechnology Technical Committee by March 2018. The 3 parts document provides general requirements on AM product (part I), and best practice guidance for AM suppliers (part II) and users (part III). The TS documents were written considering risk and compliance for each group of products. Nonetheless, the cost and scale of critical components is still an area of growth.
For more on raw and ancillary materials, look out for the upcoming Phacilitate summit. Akron will chair the Supply Chain Track at Phacilitate’s 2018 Cell and Gene Therapy World summit, which will be held at the Hyatt Regency Hotel in Miami, January 22- 25. More information on the symposium can be found here.
Exclusively for our readers, we offer a discount code if you register by the early bird deadline of October 15, 2018. Use code AKRON20 to receive 20% off the registration fee. Click here to register.