Cell Processing and Vector Production

Baylor College Of Medicine, Houston TX

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY/ABSTRACT: CELL PROCESSING AND VECTOR PRODUCTION (CPVP) SHARED RESOURCE The Cell Processing and Vector Production (CPVP) Shared Resource (SR) provides manufacturing of therapeutic grade cellular therapy products and viral vectors for use in early and intermediate phase clinical trials. These products must be prepared according to current Good Manufacturing Practices (GMP) as mandated by the U.S. Food and Drug Administration (FDA). The CPVP SR provides the infrastructure and environment to prepare, test, and release these products for clinical use. The SR consists of a state-of-the-art facility with 22 manufacturing clean rooms and support facilities, including quality control, flow cytometry laboratories, and material management facilities, and highly experienced manufacturing and quality control and assurance staff. Over the last 25 years, CPVP staff have manufactured more than 7,000 cellular therapy final products and countless intermediates, and >75 clinical grade viral vectors, as well as master and working cell banks in support of more than 60 IND studies and local and national clinical protocols. During this period, the facility was designated as a National Gene Vector Laboratory and as a National Somatic Cell Processing Facility under a contract from NHLBI Production Assistance for Cellular Therapy (PACT) program. Manufacturing services are supported by a dedicated specialized flow cytometry laboratory, which performs >13,000 tests annually; a quality control laboratory performing in-house testing and environmental monitoring (>25,000 tests/year); and an independent quality assurance group, which oversees compliance. The program is accredited by the Foundation for the Accreditation of Cellular Therapy, the College of American Pathologists, and under the Clinical Laboratory Improvements Amendments. The Cell and Vector Production facility is registered with the FDA. Under the aegis of the Dan L Duncan Comprehensive Cancer Center (DLDCCC), the CPVR SR collaborates with investigators to develop clinical scale manufacturing procedures, and release test specifications, testing procedures, quality assurance oversight, and regulatory assistance to assist in IND submissions. The SR has facilitated the transition of cellular and gene therapy products from the basic science laboratories in the DLDCCC into early-phase clinical trials. In addition to manufacturing responsibilities, the staff are experienced in transitioning research processes into GMP-compliant procedures and providing regulatory advice. The CPVP is currently supporting 35 DLDCCC clinical trials, of which 25 are investigator-initiated cell therapy studies conducted under IND led by DLDCCC investigators. Within last five years, we have manufactured products for more than 500 patients at a much-reduced cost compared to commercial manufacturing and testing entities. We also have implemented plasmid manufacturing in response to requests from users. In response to user feedback, we have introduced lentiviral vector manufacturing to allow investigators to transfer larger genetic cargoes and reduce product manufacturing times and to extended GMP-compliant gene and base editing methods for targeted changes in specific genomic loci of gene modified cell therapy products.