Featured CMO:   Cytovance Biologics, Inc.

Cytovance® Biologics offers significant value to biopharmaceutical development programs by providing full service manufacturing solutions to advance recombinant protein, antibody and cell-based therapeutic products rapidly and cost-effectively from the bench, through clinical development and to commercial launch.  In addition to its cGMP manufacturing services, Cytovance offers Cell Line Development, Process Development, Cell Banking, Microbial Manufacturing and Fill/Finish.

Manufacturing occurs in our custom-designed facility that supports multi-product cGMP production of therapeutic proteins from mammalian cell culture and microbial systems and meets the latest international regulatory standards, including current Good Manufacturing Practices (cGMP), the latest European regulations and International Standard ISO 14644 "Cleanrooms and Associated Environments".  The design was reviewed in a Type C meeting with the US Food and Drug Administration prior to construction.

This 44,000 sq. ft. facility features primary production in cell culture suites containing bioreactors at 100L (w/v), 500L (w/v) and 1,000L (w/v) scale under ISO 7 classification.  Recovery and purification occurs in adjacent independent ISO 7 suites.  The facility features an ISO 6 classification suite used for small scale cGMP liquid fill and finish operations.  Microbial fermentation is at the 100L scale.

Cytovance operates an adjacent 6,000 sq. ft. cGMP clean room facility with cell banking and PD operations and two additional suites for pilot production or custom processes.  QC labs are located in an adjacent third facility.

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