Our core expertise is in optimizing bioprocess to establish high yields of target protein in upstream and high purity and recovery in downstream without compromising quality. We have invested in high-performance technologies that support robust and efficient processes that are easier to scale up. We offer efficient tech transfer of developed processes that follows a structured approach with predictable outcomes. The tech transfer can be to customer’s facility or our own manufacturing facility. We offer integration of Process Analytical Tools (PAT) during process development & scale up and also offer expertise in process characterization studies using scale down models.
We offer process development & scale up services in both microbial & mammalian expression systems. In microbial, we offer our experience in expressing proteins as inclusion bodies, soluble or periplasmic proteins. We have expertise in optimizing fermentation processes to establish high expression yields.
We have expertise in developing high recovery purification processes for both microbial & mammalian systems. Our expertise includes developing processes such as chromatography, filtration, precipitation/crystallization, virus removal & inactivation. We incorporate QbD principles in purification process development. We have capabilities to handle Drug substance in both liquid and lyophilized formats from mg-to-gm scale.
We offer our experience in developing injectable formulations in vials, prefilled syringes & cartridges.
Excipient screening studies
Stability studies - at different temperature conditions as per ICH guidelines
Thorough analytical characterization of formulations as well as comparison studies