AABB’s new Cellular Starting Material (CSM) Qualification is a program designed to accelerate supplier qualification for biotherapies companies relying on AABB-Accredited facilities to support advanced therapies.
Subject matter experts provide an independent and objective assessment of the facility’s quality system, including policies, procedures and practices.
Nearly 200 facilities have already achieved AABB CSM qualification - and hundreds more are in process worldwide!
CSM-Qualified Facility Directory: Biotherapy companies can easily search facility listings by name, address, city, state, zip code and country.
An AABB CSM Qualification demonstrates that a facility has a comprehensive quality management system that addresses:
For information on AABB CSM-qualified facilities, please contact biotherapies@aabb.org.
AABB accreditation demonstrates a commitment to the highest standards of quality and safety and a dedication to continuously improving operations.
AABB-accredited facilities achieving the CSM qualification have demonstrated that their quality system meets or exceeds AABB’s evidence-based Standards for the collection, storage and/or processing of cellular starting materials. Dozens of AABB-accredited facilities have earned the AABB CSM Qualification and many more are in the qualification process.
AABB’s CSM-qualified facilities undergo an assessment every two years by independent and objective subject matter experts, who evaluate that the facility maintains a comprehensive quality management system for cellular starting material. AABB assessors are among the most qualified professionals in the field as recognized by ISQua.
The basis for assessment includes compliance with AABB Standards, Code of Federal Regulations, international reference standards, and local, state and federal guidance documents.
Learn More About Becoming a CSM-Qualified Facility
4550 Montgomery Avenue
Suite 700, North Tower
Bethesda, MD 20814
301.907.6977
