The Process Development Laboratory is a 2,600 SF facility focused on the development, scale-up, and analytical testing of cell and cell-based biologics to expedite tech transfer of client processes into the cleanroom.
Process Development scientists lead tech transfer projects to ensure key process parameters are clearly defined and Critical Quality Attributes reproducibly meet specifications.
GenCure’s Process Development scientists utilize easily scalable unit operations to streamline Process Development scale up and tech transfer in both traditional static tissue culture plastic and bioreactor cell culture systems.
The Process Development Lab is equipped to perform Design of Experiments (DOE) studies to inform process improvements, then seamlessly scale the process. Additionally, GenCure will help clients identify the materials and techniques needed to effectively scale-up and close a process so that it translates into clinical manufacturing.
Using state-of-the-art analytical testing equipment, GenCure’s Process Development team can identify key process parameters that will ensure manufacturing reproducibility.
The team helps clients identify appropriate cellular therapy manufacturing processes for optimal clinical batch production.
GenCure Process Development scientists ensure that all aspects of a process are ready for cGMP manufacturing. We evaluate equipment for appropriate application and ensure that all equipment necessary for clinical production is appropriately qualified.
Process Development scientists will draft complete batch records, including electronic batch records that provide streamlined post-production review and product release.
The team evaluates starting materials and raw materials and verify that these materials meet cGMP compliant specifications.
The scientists who have developed and optimized a process in the Process Development lab will train the operators for clean room manufacturing to maintain consistency of manufacturing.