Our goal during upstream process development is to develop high titer, scalable production processes that will express our customer’s target molecules expressed via microbial fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.
Upstream Solutions for Long Term Success
Furthermore, we can generate and qualify scale down-models and fully characterize process parameters in support of process validation. Extensive use is made of DOE approaches, with the support of in-house statisticians.
Upstream Development Activities include:
- Process Transfer-in and Development
- Process monitoring
- Recovery of Solids or Soluble Material
- Cell Disruption
- Supply & Toxicology Study Supply Batches
- Process Characterization