CABP CE Eligible

The use of viral vector systems to modify human allogenic and autologous cells are rapidly becoming the primary method to genetically engineer these cells to target malignancies, solid tumors, blood cancers, and cells involved in autoimmune disorders. The manufacturing, production, and use of these viral vector systems requires unique laboratory (e.g. biosafety level 2) and production controls (e.g. RCV testing) not commonly found in standard blood and biotherapy facilities that only handle the final cellular therapy product. Additionally, production facilities, bioreactors, and process scalability must be considered. This presentation will cover the following: Types of viral vector systems utilized to transduce, modify, and subsequently express proteins in cells and tissues removed from humans for eventual transplantation. This will include examples of pertinent quality and safety standards used in virus production facilities. Hazards posed by these viral vectors and transduced cells, the risk and exposure assessments conducted on these hazards, the controls needed to mitigate these risks, and the procedure to follow when spills and exposures occur. Equipment, methods, and practices required to safely produce viral vectors, conduct ex-vivo transductions, store transduced cells, and prepare the cells for administration, as well as all applicable FDA regulations and accreditation standards. Importance of reviewing sponsor’s documents (CMC, study protocol, investigators brochure, and pharmacy manual) associated with human clinical trials and the roles of IBCs, IRBs, CROs, CDMOs and CMOs. Pertinent accreditation bodies and standards for human cellular therapy. GMP facility design, commissioning, and post construction strategies that will help ensure viral production and transduction facilities, as well as cellular therapy laboratories, are compliant and meet the needs of the institution and end users. Concerns and considerations with retrofits, renovations, and equipment installations needed to support viral vector production facilities and cellular therapy laboratories. The quality programs, documents, and systems designed to keep cellular therapy laboratories and production facilities compliant, safe, and productive.

Reuben Anderson PE

Senior Electrical Engineer, Merrick

Appearances