4 services found

Cytovance Biologics services

Analytical Services

At Cytovance® Biologics Analytical Development Laboratory, we have the expertise to develop analytical methodologies and design testing plans to meet your individual product needs. Our experienced scientists will guide your method development, optimization strategies, and specialize in creating product specific methods to measure process-related performance. In addition to developing product specific methods, our staff has extensive experience in transferring and optimizing methods developed at any stage and preparing standard operating procedures which have the performance to be used in a quality control laboratory. Cytovance® also offers several platform method technologies which we can evaluate as appropriate methods for your product, this can decrease method development time and help drive more cost-effective analyses.

CGMP Manufacturing Services

Cytovance® provides a state-of-the-art, full-service manufacturing solution. We provide CGMP manufacturing, process development, and manufacturing support. Our manufacturing services include: CGMP Mammalian Manufacturing up to 2,000L, CGMP Microbial Manufacturing up to 1,000L, CGMP cell banking (microbial and mammalian), Flexible and Customized GMP Manufacturing, R&D, Cytograde™ and CGMP Grade Plasmid Manufacturing. Cytovance occupies 140,000 sq. ft. of manufacturing space. This includes segregated Mammalian, Microbial, and Flex manufacturing suites with an independent state-of-the-art warehouse. All of these facilities are custom designed for multiproduct CGMP production of biopharmaceuticals.

Mammalian Cell Culture Services

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.

Quality & Compliance Services

All of our manufacturing and support operations are built on the framework of a comprehensive quality management system. Our quality management system is designed to ensure procedural and operational excellence across the organization.