Keys to Establishing a Robust Mammalian Cell Line Development (CLD) Platform

Risk management and the establishment of a robust mammalian cell line development (CLD) platform is key in the effort to bring biologics into the clinic as quickly as possible while also achieving high productivity and maintaining expected product quality. Utilizing the same mammalian cell platform early in the lead molecule discovery efforts as that used for eventual GMP production provides critical manufacturability and developability data while also delivering consistent cell culture growth characteristics and product quality and titer information to mitigate risks during development. Being able to identify issues that may arise with the protein expressed during early R&D efforts will help circumvent costly and timely issues once into GMP manufacturing. Through years of R&D, WuXi Biologics has developed the WuXiaTM CHO-K1 cell line development platform using an advanced LDMS and continuous learning tools such as our proprietary codon optimization platform, along with state-of-the art high-throughput instrumentation, NGS-sequencing and sophisticated data analysis, and automated cell imaging clonality determination equipment. The WuXia CLD platform is integrated throughout our comprehensive Contract Research, Development and Manufacturing Organization’s (CRDMO) target to market service offering. That is, it is not just used for the clinical and commercial GMP production of biologics. The performance of the cell line platform throughout the transient expression, stable pool, stable clone, GMP cell bank and manufacturing stages are highly correlated. Because early R&D activities and developability studies using the WuXia cell line system is so indicative of future stable clone performance, it can give our clients a head start in understanding key product quality attributes and product titer. This high quality, high-performing CLD platform for biomanufacturing (6.0 g/L average titer before cell culture or media optimization) has been utilized by hundreds of clients for the delivery of clones and GMP cell banks with superior product titer and quality attributes and accepted by regulatory agencies across the globe.