Purification at cGMP Contract Manufacturing Company, Cytovance Biologics
 
 

Purification

Following cell culture or microbial upstream production, Cytovance will purify your bulk drug substance according to process transfer protocols or parameters established during process development. Cytovance’s dedicated purification facilities accommodate all appropriate methods and scales of chromatography, filtration, and viral inactivation/clearance which will be applied to achieve each unique product’s purity requirements. The substance is either packaged as purified bulk drug substance or moved to our fill/finish facilities for final drug product manufacturing.

Capabilities include:

    • Capacity available on campaign basis
    • GE Chromatography Systems utilizing Unicorn software (include multiple AKTA 10mm BioProcess, 1" Bioprocess, AKTA Ready disposable flowpath, and AKTA Pilot systems).
    • BPG, GE, and Millipore chromatography columns (up to 80CM)
    • Sci-log, Pall and Millipore UF/DF skids
    • Depth and inline filtration (includes viral filtration)
    • Virus inactivation
    • Pegylation
    • Buffer preparation
    • Clean in place

Contact us for additional information on this service or to request a proposal.