Process Development (PD) - viral vector manufacturing

We draw on our manufacturing and quality expertise to design processes that optimize product yields and minimize regulatory risk. Upstream Services: ⦁ Thawing and expanding cells for production scale ⦁ Host cell line screening and selection • Transfection or infection optimization ⦁ Media screening, feed strategy ⦁ Cell growth dynamics ⦁ Adaptation to animal derived product-free, suspension-based or adherent processes ⦁ Bioreactor optimization and scale-up ⦁ End of Production (EOP) cell evaluation Upstream Capabilities: ⦁ Sartorius Glass bioreactor 2 L, 10 L ⦁ STR tank, single-use Sartorius bioreactors 50 L, 200 L ⦁ iCELLis Nano ⦁ HYPERStacks, Hyperflasks ⦁ Cell Factories ⦁ Roller Bottles ⦁ Shake flasks ⦁ Microcarriers ⦁ Multiple DOE studies in flasks & bench-top bioreactors Downstream Services: ⦁ Purification and recovery of recombinant proteins and viruses ⦁ In-house column packing and qualification ⦁ Resin screening and selection ⦁ Column cycling and aging studies ⦁ Reduction of process residuals ⦁ Scale down modeling for viral clearance Downstream Capabilities: ⦁ AKTA pilot, chromatography ⦁ AKTA Pure, chromatography ⦁ Q Sonica ⦁ KrosFlo KMPI TFF systems ⦁ KrosFlo KR2I TFF systems ⦁ Centrifugation and Ultracentrifugation Integrating expertise in translational science together with operational excellence to solve challenging PD problems: ⦁ Holding the same platforms in PD are in GMP suites ⦁ Translated more than 100 product processes from bench to GMP suites ⦁ Helping companies define and optimize their processes to produce material that will enable them to proceed to early phase trials ⦁ Providing expertise in process optimization; > 80% of our biomanufacturing clients rely us for this ⦁ Working as an extension of your team, guiding you through scale-up processes to achieve GMP compliance ⦁ Customized, comprehensive product development plan—outlining each step and highlighting risk