Services

Upstream Process Development

Our experienced upstream team has developed highly productive and scalable fed-batch (FB), intensified FB (IFB), and continuous perfusion (CP) platforms to produce high-quality protein therapeutics in support of your clinical development and commercialization. By implementing these platforms, we can ensure speed to process lock, streamlined process optimization and characterization, and successful scale up to clinical or commercial production.

Key Features of Our Upstream Process Development Platform

Speed: By leveraging our cell culture platform experiences and deep process knowledge, we can establish a robust and productive manufacturing process within 10 weeks from receiving top clones or 6 months from receiving DNA sequence.
High Productivity: Based on the historical data we have generated, our FB process titers range from 3.3 to 9.9 g/L. Our IFB process can double the output on average. Additionally, our CP process can increase output by more than 10X compared to the FB process, achieving volumetric product rate (VPR) of up to 8 g/L per day. At 8 g/L per day, one single-use 500L bioreactor can produce more than 700Kg of DS per year.
Enhance Product Quality: Our perfusion cell culture processes improve product quality by maintaining optimal “steady state" environments, ensuring cell viability to be above 90%. The steady-state environment is achieved through the continuous removal of metabolic byproducts and replenishment with well-designed production media, along with optimal control of cell density, culture pH, pCO2, pO2, and temperature. The product is also continuously harvested from the bioreactor, minimizing exposure to degrading proteases and other enzymes. Consequently, less stable products, such as bi- and multi-specific antibodies produced under perfusion process, tend to exhibit fewer impurities and more consistent product quality.