From CLD To CDMO: Demonstrating A Successful Cell Line Technology Transfer

Cell line development (CLD) requires significant expertise and resources, leading many organizations to outsource these activities to industry partners to expedite the time-to-clinic. Often, these collaborations extend to contract manufacturing organizations (CMOs) or contract development manufacturing organizations (CDMOs) that offer the equipment, consumables, and expertise needed for upstream manufacturing.

The role of the CLD partner extends beyond delivering a research cell bank (RCB). It includes a thorough understanding of scaling to commercial production, navigating a complex and ever-changing regulatory landscape, and ensuring successful technology transfer to the manufacturing facility. Biopharmaceutical developers benefit the most from partners that provide comprehensive services, equipped with the knowledge and expertise to advance their project from early CLD to the investigational new drug (IND) application.

This white paper explores critical considerations for both biopharmaceutical developers and CDMOs during technology transfer. It also presents a case study demonstrating the successful transfer and scale-up of a cell line from the 4Cell® CHO platform to a global CDMO.