Cytovance Biologics has extensive experience with batch and fed-batch fermentation of E. coli and Pichia. Fermentation processes are demonstrated in process development and scaled-up for cGMP operations in our state-of-the-art facility. The production team works in tandem with the tech transfer group to ensure a seamless transition from bench to clinic.
Cytovance Biologics manufactures and cryostores Master and Working Cell Banks to support present and future production requirements. Microbial Cell Banks are cryostored in the vapor phase of liquid nitrogen freezers. Cytovance Biologics manages and coordinates all required testing per FDA and ICH guidelines.
Cytovance Biologics’ manufacturing team is highly experienced and has an excellent track record with process-scale fermentation. With production capability in 10L, 200L or 1000L stainless steel, and 300L SUF, our fermenters can accommodate the majority of microbial biologics production campaigns. Fermentation experts at Cytovance routinely work with a wide range of feed strategies, media formulations, and inclusion body recovery techniques.
Purification and Bulk Fill
Cytovance has extensive experience with an array of purification capabilities to meet your cGMP production needs. Purification suites at Cytovance are segregated and customized with equipment to specifically meet the requirements of each client process. Single-use options are available throughout all purification steps with cutting-edge technologies. Purification personnel at Cytovance are experts with protein refolding, multiple chromatography techniques, tangential flow filtration, and bulk drug substance filling.