GMP Protein Production

Waisman's recombinant protein process development and manufacturing services fully embrace our collaborative and flexible approach to product development. Our strength lies in the ability to develop a customized process that is reproducible and fully scalable, yielding an end product that meets industry standards for FDA submission, while meeting cost and timeline constraints and working as a true partner.

Protein Production Specifics

• Wide variety of bacterial or mammalian host cells experience for production
• Design of Experiment approach to initial screening and optimization
• Automated chromatography and TFF skids to facilitate tech transfer and production of large product lots
• Downstream processing expertise that includes column chromatography, protein refolding, tangential flow filtration, and microfiltration

Fermentation/Cell Culture Capabilities

• 30 liter steam in-place fermentor
• 50-250 liter single use bioreactor for suspension cells
• Multi-tray Cell Factories for attachment dependent cells

Downstream Purification Capabilities

• Cell harvest by continuous centrifugation or filtration
• Cell lysis (chemical or mechanical methodologies)
• Supernatant concentration / buffer exchange
• Column chromatography
• Protein refolding (100 liter chilled tank)
• Tangential flow filtration (TFF)
• Ultrafiltration

GMP Protein Production Highlights

• Bacterial / mammalian hosts
• Multiple bioreactors and multi-tray formats
• Cell harvest by centrifuge or filtration
• Protein refolding
• Scalable downstream processing