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Upstream Process Design

Vials, bioreactors, wave bags, SUBs | target titers and product profiles | QbD approaches | modeling and analytics | metabolic flux, turnover, pathway | fast efficient CMC work 

We treat your biologics platforms with the care they deserve, working across vials and shaker flasks, into multiscale bioreactors, wave bags and single use platforms in our state-of-the-art process development labs and pilot plant. Our experts conduct phase appropriate design on standard and advanced therapeutics including mAbs, vaccines, ADCs, cell and gene therapies. 

We collaborate with you closely to define target titer ranges and product quality profiles and keep bioreactor design and control strategies in mind during early-stage upstream process design. We use QbD approaches from first principles, modeling processes before entering the lab and using offline, at-line and inline analytics, to better understand metabolic flux, turnover and pathway. 

The result is fast and efficient CMC outcomes and a high performing upstream process, that can be scaled-up and manufactured easily, helping you hit timelines and address your patients’ needs.