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 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.