Biotherapeutics
Overview
The BT Core provides collaborative process development support to investigators across the Center engaged in new Biotherapeutics initiatives. Core staff are responsible for converting research-lab processes into GMP-compliant manufacturing processes. This includes establishing Standard Operating Procedures (SOPs) and batch records for cell processing, cell engineering, and vector production. The Core provides full support for cGMP manufacturing of cell products: the Core handles patient cells in a cGMP environment, from purification and transduction to expansion and formulation, for use in phase 1 and phase 2 clinical trials. The facility also manufactures vector stocks to support these trials. The Core also oversees biosafety and release testing of generated projects for human use. This includes analysis of patient cells and vector stocks, assessing characteristics such as phenotype, potency, purity, and stability. Gene transfer and expression analyses are also performed. The Core performs analytical post-infusion monitoring. For each trial, the Core develops a comprehensive set of analytical tests to ensure quality and safety of the manufactured drug products. While some tests are common across trials, new assays can be developed and validated as needed. Finally, the BT Core serves as an experienced resource providing technological and regulatory expertise in the requirements for cell therapy production and deployment both in preclinical and clinical contexts. This includes expert guidance on GxP, FDA, and RAC-NIH standards, assisting Center investigators in developing protocols and documentation for Investigational New Drug (IND) submissions to the FDA.
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