My name is Amy Austin, senior r. director, quality and process improvement, at Carolina BioOncology Institute (CBOI). CBOI features a cancer research clinic for phase I immuno-oncology trials, which includes a dispensing pharmacy and an AABB-accredited apheresis program. CBOI also incubates an internally sponsored research company, BioCytics, Inc., which includes sponsor-investigator initiated preclinical, clinical and adoptive cell therapy trials, CRO/CDMO capabilities, a diagnostic clinical laboratory, and a human applications lab (cell processing facility).
CBOI is not only a community-based phase I clinic, but its sister company, BioCytics, is located in the same building. While patients are coming to the clinic on one side of the building for their treatments, our staff are actively processing and developing cells for therapeutic purposes in the BioCytics human applications lab. BioCytics' purpose is to bring cellular therapies directly to patients. Our main goal is to be a single facility that can leukapherese, grow immune cells, and dose patients in phase I investigational new drug (IND) studies.
I am extremely proud of the clinic's ability to continually grow, expand and even pivot as needed while we work toward our goals. As a small clinic, we are able to efficiently bring on new projects and create new processes and procedures while always ensuring that we stay compliant.
Brent Dixon, PhD, our chief technology officer, shares that BioCytics is able to capture multiple cell fractions from the leukapheresis product, enabling a variety of research and development activities previously limited by blood draws. This allows for different cell types and sub-populations to be explored for cell therapy applications. Leukapheresis also enables deep biomarker analysis at the cellular and molecular level for potential prognostic, diagnostic and therapeutic enabling studies. Multiple studies can be conducted from a single leukapheresis to enhance analytical precision and process optimization furthering research. These precious blood products from healthy donors and especially cancer patients drive forward patient-centric cellular therapy technology development through the BioCytics warm-chain platform for the most robust and effective immune cells.
Amy Austin, Sr. Director, Quality and Process Improvement, Carolina BioOcology InstituteBecoming AABB-accredited was beneficial for not only our apheresis program but our entire clinic as well. Having excellent guidance and expectations to meet to ensure that each department is up to the highest standards gives us the confidence to evolve and offer additional services. AABB accreditation provides robust standards that are peer-reviewed by experts in the field with objective guidance documents and examples. The fact that it is centered around quality improvement and education makes it a positive experience for the team. Accreditation by AABB helps to ensure we keep current with industry best practices and regulatory changes with clear and consistent guidance from experts in the field.
We are preparing an FDA IND submission in 2025-26 to open a phase I trial for our autologous adaptive cell therapy platform. BioCytics also plans to expand its biotechnology R&D, cell processing facility, biorepository, personnel, and additional software. In the long-term vision of John Powderly, MD, founder and president of CBOI and BioCytics, autologous adaptive cell therapy will expand beyond our clinic. The ultimate goal is that many more patients have access to these services by scaling this platform to other locations across the country.
I would encourage them to absolutely consider AABB accreditation. It sets us apart from other facilities and provides superior support to our staff as we work to maintain a compliant program.
In 2005, John Powderly, MD, founded both CBOI and BioCytics as reflections of the same vision to deliver autologous immune cell therapies manufactured at the point of care for early phase clinical trials. He states that, “We believe the future of bespoke regenerative medicine depends upon regional human application labs as an efficient, affordable and accessible delivery system. Our recent AABB accreditation is another step closer to realizing our vision to enable future cellular immune cures for solid tumor cancer patients.”
Special thanks to our apheresis team: John Powderly, MD; Sherene Banawan, PA-C; Victoria Prevette, BSN, RN; Bryanna Veneri, BSN, RN; Akiko McCullough, BS, RN; Alexis Rodriguez; Kayla Hunt, BSN, RN; and our BioCytics clinical development team: Shruty Lakdawala, MD; Camila Vedia, BS; and Karishma Mathur, MD.
Since 2005, patients with late-stage cancer have been seeking rapid enrollment access at Carolina BioOncology Institute for innovative immunotherapy trials, sometimes years before these treatments are widely available. John Powderly, MD, founded Carolina BioOncology Institute with a passion to help serve the cancer community as the only independent phase 1 clinical trial clinic in the region for cancer care. Powderly’s team has grown to more than 45 staff members, including clinicians Neel Gandhi, MD, and Sherene Banawan, PA, to support its expansion. Incubated within Carolina BioOncology Institute is a human applications lab called BioCytics, Inc. BioCytics is developing individualized cell therapies known as autologous adaptive immune cell therapy. This pioneering research is currently in the preclinical phase and has been part of Powderly’s vision for more than 20 years.
AABB Accreditation is an international mark of excellence that demonstrates your facility's commitment to quality and safety. Biotherapies facilities can become AABB-Accredited via the Standards for Cellular Therapy Services.
Learn how AABB Accreditation can bring value to your facility.
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