Overview
Cytovance® Biologics is a US-based biopharmaceutical CDMO excelling in the rapid, cost-effective development and manufacture of large molecule APIs from mammalian cell culture and microbial fermentation such as monoclonal antibodies, antibody fragments, bispecifics, enzymes, fusion proteins, vaccines and other biological products. In addition to our clinical and commercial cGMP API manufacturing, Cytovance offers integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. Our program management team coordinates all critical CMC activities around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.
R&D Services offer mammalian Cell Line Development, Microbial Strain Development using Cytovance Biologics’ Keystone™ Expression System, research cell bank production, Process Optimization of Upstream and Downstream Development, Technology transfer, Process optimization using statistical Design-of-Experiments (DoE), scaled-down model development and Process Characterization using a QbD framework.
Analytical Development ensures a seamless transition into Quality Control for in-process and release testing. Core competencies include method development, method transfer, method optimization, method qualification, pre-formulation development, and product characterization. For early phase customer needs Cytovance offers Manufacturability Assessments for antibodies, other mammalian expressed proteins and Expression Feasibility Studies for microbial expressed proteins.
CGMP Process Development and Manufacturing is a core competence for mammalian and microbial products from the clinic to commercialization. Our manufacturing success rate exceeds 95%.
Program Management is our highly efficient, centralized, and responsive team that coordinates all critical chemistry, manufacturing, and controls (CMC) activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support.
Quality is the bedrock our business is built upon. Our regulatory compliance group strives to be among the best in the industry. All of our clients’ products are manufactured to the highest standards.