Manufacturing

QSV Biologics offers full cGMP manufacturing services for the production of Bulk Drug Substances (BDS). Our capabilities include a wide variety of microbial and cell culture expression systems for the production of therapeutic proteins. Four manufacturing suites are currently in operation with plans for additional suites currently under development.

     cGMP Manufacturing Suites:

• Dedicated Pure Steam Generators for fermentation and purification suites; condensate meeting water for injection specification
• Dedicated HVAC units in Fermentation and Purification Suites
• Dedicated Purified Water systems meeting current USP specifications for fermentation and purification suites
• Plant steam for fermentation suite
• Oil-free air compressors
• Chiller unit
• Dedicated Glassware Decontamination/Washing
• Receiving and Material Control Laboratory

     Manufacturing Services:

• Technology Transfer
• Cell Bank Development and Storage
• Assay Development and Validation
• Process Development and Validation
• Process Scale Up
• Quality Assurance Support
• cGMP Manufacturing for Phase I-III and Commercial Supply
• Batch Records and cGMP Documentation
• Final Product Stability Testing
• Dedicated Project Management