Cellular Products Laboratory (CPL)

Overview

The Cellular Products Laboratory (CPL) is dedicated to generation and preparation of quality products for tumor vaccines and for cellular and gene therapy of cancer. This laboratory has assumed an increasingly important role in supporting the conduct of novel immunotherapy and gene therapy clinical trials at the UPCI. It performs 5,500 procedures annually, which vary in complexity from large-scale cell production to smaller cultures for research and pre-clinical studies.

Responsibilities of the CPL include cell culture of hematopoietic or non-hematopoietic cells, vaccine preparation, genetic modification of human cells, tissue procurement and processing for clinical trials, sterility and safety evaluations of generated products prior to their release for administration to patients, and development of new products and procedures for use in future clinical protocols. The CPL pilots preparation of new cellular products and assists investigators in preparation of INDs. Once IRB and FDA approvals are obtained, the CPL produces and delivers therapeutic-grade cells to the bedside. Recently, generation of dendritic cell (DC)-based vaccines and research associated with therapeutic DC generation have been the major effort, representing nearly 80% of CPL production activities.

The CPL is operated according to FDA criteria for current good manufacturing practice (cGMP). The CPL has established an excellent record of accomplishments and its unique expertise has enabled rapid translation of novel technologies to clinical trials.