The downstream process development group will develop a process to reduce product related (aggregates, fragments, charge variants) and process related impurities (host cell protein, host cell DNA, and residual resin ligands) to industry standard levels. Using our cell line development platform, we are able to use stable pool material to start downstream process development which enables earlier process lock. After process development, the process will be scaled up to run in either a 100 or 200L pilot run prior to GMP manufacturing.
Modalities: Depth Filtration, Chromatography, Viral Reduction, Tangential Flow Filtration, and Sterile Filtration
Development: Loading / Binding capacities, filter and resin lifetime study, scale up, scale down, viral clearance, process optimization, process characterization, raw material cost analysis
The downstream process development team uses two approaches to meet client objectives: platform based or customized. The platform based approach can reduce service cost and allows for a reliable and robust process to be quickly transferred to manufacturing. The customized process takes more time, but will have higher yield and lower raw material costs. We have the ability to develop, transfer, or optimize a process depending on client’s needs.
• AKTA Avant
• AKTA Process
• AKTA Pure
• KR2 lab scale TFF
• Millipore pilot scale TFF
• 100L, 200L and 500L mixers