Kincell Bio’s growing services and capabilities help start ups and academic spin outs achieve early-stage cell therapy development.
Our early CMC and process development helps transform academic and start-up processes into commercially viable therapeutics. Kincell Bio supports innovators in bridging the gap between laboratory research and clinical development, supporting smart decision-making early on to facilitate later CMC success. We also help you understand the risk associated with making process and method changes early vs. later in clinical development and can help you plan for success and invest accordingly.
Our expertise lies in translating innovative research into a commercially viable cell therapy product by establishing robust processes, methods and documentation during early development, helping to ensure regulatory compliance and streamline future clinical manufacturing.
From leadership to project management, you can expect expert CMC advice, robust quality management, and informed scientific conversations from Kincell’s experienced scientific staff. Our talented staff can help you identify your key product attributes, target product profile (TPP), and build a phase-appropriate CMC strategy to help expedite your path to the clinic.