Mammalian Cell Culture
One of Cytovance’s core services is recombinant protein drug substance production derived from mammalian cell culture. Production processes formalized during process development are executed under cGMP 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. Cell culture is scaled-up into our traditional stainless bioreactors or single-use bioreactors to meet a variety of process scales and requirements.
Cytovance Biologics manufactures and cryostores Master and Working Cell Banks to support present and future production requirements. Mammalian 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’ experienced manufacturing team is well-equipped to execute mammalian cell culture production campaigns. With production capability in 250L or 1000L disposable bioreactors or in 100L, 500L, and 1000L stainless steel bioreactors, our bioreactor trains can accommodate the majority of biologics drug substance requirements. Single-use options are available throughout all cell culture expansion and terminal bioreactor steps.
Purification & 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 multiple chromatography techniques, tangential flow filtration, and bulk drug substance filling.