Become AABB-Accredited: Biotherapies Services

AABB offers accreditation of biotherapy services around the world.

Why Biotherapies Accreditation

  • AABB Accreditation’s quality systems approach allows for controlled innovation and permits a variety of methods to comply with standards requirements, allowing establishments to apply them to a broad range of cellular therapy services.
  • Accreditation from AABB validates—without question—that your practices meet the highest levels of quality and safety. It is an endorsement of your processes and procedures, and a strong reassurance that patient safety is paramount in your facility.
  • AABB Accreditation provides staff with the confidence to test and validate new techniques that further increase efficiency and improve, knowing your facility is already operating at the highest level of quality.
  • The activities required for AABB Accreditation can provide a basis for your facility’s development of SOPs, quality and vendor agreements, and other documents.
  • Close interaction with our member experts and federal agencies affords AABB a unique position from which to represent and support our member institutions, including in providing timely, easy-to-understand updates on regulatory changes, compliance issues, emerging risks and more.
  • Insurance companies, referring physicians and patients themselves look to AABB Accreditation as the gold standard for quality and safety in blood and biotherapies.

Learn more about the accreditation process, including accreditation phases and expectations, and steps to become accredited.

Biotherapies facilities can become AABB-Accredited via the Standards for Cellular Therapy Services. Examples of applications include the following activities:

Hematopoietic Progenitor Cell (HPC) Activity*

A facility involved in any of the following: qualifying donors, collection, processing, storage, distribution/issuing of HPC products.

Cord Blood (CB) Activity*^

A facility involved in any of the following activities: qualifying donors, collection, processing, storage, and distribution of cord blood products.

Somatic Cell Activity*

A facility involved in any of the following activities: qualifying donors, collection, processing, storage, and distribution of somatic cell products other than HPCs or CB.

Cell Therapy Clinical Program Activity*

The facility responsible for administration of the cell therapy product and related patient care activities.

*AABB can be the CLIA provider for facilities accredited in these activities.
^ A facility accredited for the Cord Blood Activity that is part of the Bill Young Cord Blood Program can have AABB be their HRSA provider.

View AABB-Accredited Facilities

Featured AABB-Accredited Facility: Gift of Life Marrow Registry

Gift of Life Collection CenterNow in its 30th year, the Gift of Life Marrow Registry cures patients battling blood cancer and other life-threatening diseases by providing donors for marrow and stem cell transplants.

In addition to having saved thousands of lives through stem cell and marrow transplants, its newest division, Gift of Life Biologics, provides cell and gene therapy developers with cellular starting material from healthy or specialized donors for further manufacture of next generation biotherapies. Gift of Life is also building a Biobank of off-the-shelf, on-demand products and cellular starting material. Gift of Life’s 70-person team is passionate about innovation, advancing cellular therapies and saving lives.

“Recognition by AABB for our dedication to quality and safety is a source of great pride for us. Since our establishment in 2019, our Collection Center has consistently met the increasing demand for cellular therapies, providing the highest quality products with exceptional service.”

- Richaele Nichiporenko, Chief Innovation Officer/Associate Director Medical Services

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