Drug Substance Process Development and Tech Transfer
Drug Substance Process Development & Technology Transfer
Our strong technical expertise can support you develop a new process or optimize an existing process across microbial, mammalian and various other platforms. Optimization of upstream and downstream parameters is critical to achieving a reliable, cost-effective biomanufacturing process, yielding optimal quality, purity and quantity.
Upstream Process
- Experience and capabilities for multiple mammalian cell types, including CHO DG44, CHOK1, HEK293, PerC6 and Sf9, as well as for multiple microbial expression systems, including E. coli, Pichia and Saccharomyces
- Extensive experience with development and scale-up of adeno virus (Serotype AD5 and AD26). Additional capabilities include Lentivirus and Baculovirus vectors
- Technical capabilities in seamlessly scaling from lab to manufacturing
- Abilities to rapidly scale from lab to manufacturing scale be effectively utilizing scale down models
- Expertise in handling various bioreactor types (SS, SUB, Wave, AMBR) for optimum throughput across expression platforms
- Fed-batch and perfusion technologies
Downstream Process
- Experience and capabilities in developing downstream processes for biotherapeutics, including monoclonal antibodies, recombinant proteins, complex glycoproteins, bacteria and yeast
- Abilities to rapidly scale from lab to manufacturing scale by effectively utilizing scale down models
- Multi-column chromatography technology, to help clients reduce clinical manufacturing cost through improved resin utilization
- Technical capabilities in seamlessly scaling from lab to manufacturing
- Optimized downstream processes to remove impurities and increase yields with minimal steps and optimal recovery, leading to cost efficient manufacturing
