CORE--Cell Processing

Baylor College Of Medicine, Houston TX

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): The Cell Processing Core provides a Good Manufacturing Practices-grade facility for the preparation of therapeutic cell products required for the clinical studies included in Projects 1 and 3 of this proposal. It consists of three components: a vector production facility (covered elsewhere in this application); a cell processing and preparation facility (CPPF); and a separate quality assurance and control (QA/QC) laboratory. The CPPF consists of more than 6,000 square feet of HEPA filtered, Class 10,000 space, divided into 8 cell preparation laboratories, a low temperature storage area, a Class 1,000 cell sorting and analysis laboratory, a large equipment area and a central supply facility. The Facility is well equipped to operate under GMP conditions, with extensive documentation systems, barcoding, environmental monitoring and quality assurance, control and improvement programs. It contains all of the necessary cell separation, culture, characterization, cryopreservation and analysis equipment to support the activities in this proposal. The staff have extensive experience in the preparation of and transduced/targeted cytotoxic T cells) for therapeutic applications. The QA/QC Laboratory provides independent testing of cellular and vector products prepared within the GMP Facility as a whole, in addition to quality control and monitoring of the environment, assistance with personnel training,performance of audits, and preparation of test reports. They will be responsible for quality control for all phases of preparation of cell products and vectors for Projects 1 and 3, and for accessioning and distribution of samples and cell lines and procuring peptide for Projects 2. They will also assure overall compliance with GMP conditions by performing environmental monitoring, record review, calibration services and by conducting regular audits of procedures and systems.