Cytovance offers a comprehensive range of development and CGMP manufacturing services for clinical through commercial to the biopharmaceutical industry, including:
Product line:
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Mammalian, Microbial, pDNA
Services:
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Cell Culture Process Development
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Cell Culture production from
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Formulation Studies
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Microbial Strain Development
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Fermentation Development
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Recovery and Purification Development
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Analytical Method Development, Qualification and Validation
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Process Characterization
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Process Validation
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ICH Stability Testing
CGMP Manufacturing – Clinical and Commercial:
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CGMP Microbial Manufacturing up to 1,000L
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CGMP Mammalian Manufacturing up to 2,000L
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CGMP cell banking (microbial and mammalian)
Support Services:
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Project Management
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Regulatory
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CMC Support
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Cytovance® Biologics was founded in 2005 based on the client-side experiences of the executive team of Novazyme Pharmaceuticals developing alpha glucosidase and other recombinant enzyme replacement therapies. Novazyme Pharmaceuticals was sold to Genzyme Corporation and the remaining team drew on its strong client-side experience, founding Cytovance Biologics. Our business model was designed from the bottom-up with the technical and business needs of the client in mind.
Cytovance occupies 140,000 sq. ft. of manufacturing space. These include segregated mammalian, Microbial, and Flex suite manufacturing suites with an independent state-of-the-art warehouse. All of these facilities are custom-designed for multiproduct CGMP production of biopharmaceuticals.
Our 50,000 sq. ft. mammalian facility features production in cell culture suites utilizing single-use bioreactors at 250L, 500L, 1,000L and 2,000L scale. Recovery and purification is undertaken in adjacent independent purification suites. An adjacent facility houses process and analytical development laboratories, and administrative offices. Microbial manufacturing capabilities include CGMP fermentation processes at 10L, 200L, 300L and 1,000L scales and downstream recovery process suites with 2 x 5,000L refolding tanks.
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