Comment Period Opens for Proposed 13th Edition of Standards for Biotherapy Services

The proposed draft Standards for Biotherapy Services (formerly Standards for Cellular Therapy Services), 13th edition, is now available for public comment until Oct. 13. A summary memo that accompanies the proposed Standards for Biotherapies Services provides a comprehensive description of the additions and edits in the draft.

Regarding the title change introduced with this edition, the AABB Biotherapies Standards Committee determined that the term “cellular therapy” no longer fully reflects the breadth of the field. The new title recognizes the expanding scope of biotherapies and better positions these standards to evolve alongside the field.

When these standards were first developed, “cellular therapy” accurately described the activities and products within their scope. Scientific and technological advances have since expanded the field to include a diverse range of cell and tissue derived therapeutic products and related services. The AABB Biotherapies Standards Committee notes that the term “biotherapies” better reflects this broader scope, encompassing cellular therapies while allowing the standards to evolve alongside the field.

Currently accredited facilities, applicants, certificate holders and assessors should note that the scope of this existing accreditation program will not change solely because of the title change, nor will the status of any accredited facility. Any future expansion of accreditation scope or substantive requirements would proceed through AABB’s established standards development, governance and implementation processes.

As with every new edition of proposed standards, there are updates in this edition reflecting advancements in science and technology. Some of these notable changes include:

• In line with the title change, a new definition of “biotherapies” has been crafted. The definition reads as follows:
  
  Biotherapies: For the purposes of these standards, biotherapies are products derived from cells or tissues that may be unmanipulated, manipulated or manufactured, and are intended for therapeutic use in accordance with applicable requirements of the appropriate Competent Authority. These standards may also apply to cellular starting materials, intermediate products and materials intended for nonclinical research that support the development of these therapies.
  
• To provide clarity, many of the director standards that appear in Chapter 1 have been deleted as presented and have been moved to two new reference standards at the end of Chapter 1.
• New Standards 3.7.1 – 3.7.4.1 focus on the use, risk management, verification of output, and monitoring of artificial intelligence in the accredited facility.
• New Standard 5.1.11 focusing on investigational products has been added to the proposed edition, ensuring that all facilities follow the processes as outlined by the IND or equivalent.
• In conjunction with new Standard 5.1.11, new Standards 5.6.1.7 and 5.6.1.7.1 have been added to address special labeling requirements for investigational products.

The AABB Biotherapies Standards Committee encourages all interested individuals to submit comments ahead of the Oct. 13 deadline. The standards in the 13th edition are in the proposed phase and will be finalized after the comment period has concluded. The committee will review all comments submitted and provide a summary document that describes the committee’s rationale for its final decisions.