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.
Cell Banking
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.
Bioreactor Production
Cytovance® Biologics’ experienced manufacturing team is well-equipped to execute mammalian cell culture production campaigns. With production capability in 250L, 1000L or 2000L disposable bioreactors or a 500L stainless steel bioreactor, 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.
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