Purification

Following cell culture 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 AKTA 10mm BioProcess  and AKTA Pilot Chromatography skids (IEX, affinity, HIC, SEC)`
• Filtration/Ultrafiltration/Diafiltration
• Virus inactivation
• Buffer preparation
• Clean in place