02.13.23 -- De-Risking CGT Therapies Early In Process Development

The rapid increase in demand is causing plasmid supply and manufacturing to become a critical pain point in the industry. To meet the rising demand for plasmid DNA, discover why process scale-up and process optimization of current production processes is needed as both upstream and downstream challenges exist.

There is no one-size-fits-all manufacturing solution for adeno-associated viral (AAV) vectors. Purity requirements, vector quantity, and other needs vary depending on the indication, size of the patient population, route of administration, and dosage required.

To prepare allogeneic, or "donor-derived," CAR T cells for commercial scale, companies must think through a number of considerations around scale-up, aseptic processing, single-use systems, facility design, starting material, supply chain, and logistics.

Finding a CDMO that can perform all the necessary testing for an AAV product, while preserving precious drug product and adhering to or accelerating timelines, can make a significant difference for a nascent company or novel drug.

While the rigors of early process development in cell and gene therapy can appear burdensome for nascent companies, prioritizing certain early studies can mean the difference between success and failure for these highly sensitive drug products.

One approach to reducing risk is to build a manufacturing process that includes validated analytical procedures and assays to promote enhanced assay performance and process knowledge to ensure high-quality and consistent products. See how to develop a comprehensive, optimal approach to assay development and product characterization.