June 22, 2022
In response to recent draft guidance on the development of chimeric antigen receptor (CAR) T-cell therapies, AABB encouraged the Food and Drug Administration to leverage existing standards and accreditation programs to ensure the safety, quality and consistency of cellular starting material (CSM).
In a June 13 letter, AABB applauded FDA for the draft guidance, which will help the industry better develop, manufacture and assess the clinical viability of CAR T cells. AABB also encouraged the agency to assure comparability and process controls rather than relying exclusively on sponsor-specific cell collection procedures. Furthermore, AABB believes that utilizing existing standards and accreditation programs will help mitigate challenges and ensure the consistency of products manufactured at several facilities.
Additionally, AABB asked FDA to specify that manufacturing of more-than-minimally-manipulated products subject to Section 351 of the Public Health Service Act (PHSA) begins after the collection of CSM. AABB also emphasized that while the principles in the draft guidance may inform other cellular therapies, they may not be generalizable or transferable to other cell-derived products.
Supporting patients’ access to safe, medically appropriate biotherapies is a key component of AABB’s advocacy efforts. Additional information is available on AABB’s Advocacy web page.