Validation of Gene Therapy Manufacturing Processes

Abstract

Specific issues of concern in the validation of gene therapy viral vector manufacturing processes include quality of raw materials, safety testing of cell and viral banks, production and purification of the vector, in-process and final-product testing, and validation of analytical methods. Since most vectors are produced in multi-product facilities, cleaning validation is a major concern due to potential product-to-product cross contamination. Viral clearance also presents a major validation challenge due to the nature of the product. As with any relatively new technology, the testing and validation requirements are still in development, but the basic principles of cGMP and process validation apply. Adenovirus vector manufacturing is presented here to illustrate a logical approach to validation of a gene therapy viral vector manufacturing process.