Ann Kemp, M.T. (ASCP), R.A.C., C.Q.A., leads industry standardization efforts for Be The Match BioTherapies and is the interim manager of our Network’s collection center auditors. With extensive firsthand knowledge of collection center operations and compliance requirements, she shared how Be The Match BioTherapies® is helping to build audit efficiencies and how the organization is moving industry standardization forward.
Q: Tell us about your background and your current role at Be The Match BioTherapies.
I am a medical technologist by training. I spent 30 years working in a clinical laboratory in hematology, immunohematology, and transfusion medicine and co-managing an autologous cell therapy lab. For the past 15 years I’ve worked in quality and regulatory, first in the medical device industry and now in the cell therapy/biotechnology industry.
In addition, I am a certified quality auditor with 10 years of experience auditing for compliance to Good Tissue Practice (GTP) and Good Manufacturing Practice (GMP), medical device quality system requirements, ISO 13485 and Clinical Laboratory Improvement Amendments. Prior to working with the Cell and Gene Therapy Operations team at Be The Match BioTherapies, I managed the audit team for our parent company, the National Marrow Donor Program® (NMDP)/Be The Match®, for five years.
Currently, as the senior manager of Quality and Regulatory Compliance and Standardization, I am the business lead for our Quality System Audit (QSA) Program. I also manage the regulatory compliance specialists who ensure we meet the FDA and international regulations as they apply to the products and services we provide to cell and gene therapy companies in clinical development or commercialization. Additionally, I work with cell and gene therapy companies, providing them with quality and regulatory information and helping them understand regulatory requirements.
Q: Why is Be The Match BioTherapies focused on industry standardization, particularly in the area of quality audits?
As a subsidiary of the NMDP/Be The Match, we have a long history of working with collection centers for our hematopoietic cell transplant business. These centers are part of our Network, and we already audit them regularly for compliance to GTP and GMP regulations.
When these centers begin collecting starting material for cell and gene therapies, they are also required to meet FDA regulatory requirements. With the rapid development of these therapies, we are seeing firsthand the stress that the audit demand is putting on the collection center infrastructure; each center may be audited multiple times in a short period of time. This puts a strain on resources as audit preparation, participation and follow-up all require staff time.
Additionally, each center has to comply with the cell and gene therapy developers’ own requirements for cell collection, processing and transport, which can vary for each company. But, the difference in these collection requirements is often very minimal, so if a center is being audited by multiple companies, there is likely to be a lot of process redundancies.
Q: What are we doing as an organization to move standardization forward?
We recently launched the QSA Program. Through this program, our experienced and certified quality auditors audit collection centers and cell therapy labs for compliance with 21 CFR Part 1271 GTP and 21 CFR Part 211 GMP. Cell and gene therapy developers are then able to license the audit results, eliminating the need to invest in expensive infrastructure and training of auditors and allowing more efficiency with onboarding centers and labs. For the collection centers, our QSA Program can mean a lot fewer audits.
We are also working on a project with the Standards Coordinating Body to look at ways to standardize the collection process for starting material for further manufacture. This effort includes gaining insights from industry leaders, including collection centers, the Foundation for Accreditation of Cellular Therapy, AABB and cell and gene therapy companies.
Q: What industry changes do you foresee in the future?
In the last six months, I have seen key stakeholders come together with a common desire to standardize the cell collection process and reduce the burden on collection centers. I think this will continue to grow as the field continues to grow. And I’m afraid that if standardization does not happen, the collection centers will not be able to sustain the current state. By coming together and finding processes that can be standardized to increase efficiencies, the industry as a whole will be able to save more patients, and at the end of the day, that’s really why we’re all here.
Download additional information about the Quality System Audit Program offered by Be The Match BioTherapies