Gene and cellular therapy manufacturing requires strict control in current Good Manufacturing Practice (cGMP) facilities. Designing a facility or finding a contract manufacturer to meet the manufacturing needs is essential for the success of gene and cellular therapy products.
Gene and cellular therapy manufacturing facilities include the manufacturing space, the storage warehouse for raw, and finished products, and laboratory areas. The manufacturing facilities must be designed for aseptic processing. Development of fully enclosed manufacturing equipment and built-in controls for in-process testing is optimal for this type of processing. Process flow needs to be considered from clinical to commercial manufacturing using a Quality by Design model to validate the cGMP manufacturing process. This involves defining the critical process parameters, process parameters and in-process tests. This information should originate from development studies and be used to define a Design Space for the validation of the process. These parameters and tests should be continuously monitored as part of an on-going process validation. This can lead to regulatory flexibility to operate in the defined Design Space and to reduced testing as a result of quality being built into the design of the manufacturing process. Join us for a discussion around the pathway from discovery to commercial manufacturing of gene and cellular therapy products.