GMP Protein Production

Waisman offers superior quality recombinant protein process development and manufacturing services. 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. All recombinant protein production campaigns are performed in either our Microbial Cell Suites or Mammalian Suites.

Protein Production Specifics

  • Wide variety of bacterial or mammalian host cells available for production
  • Well characterized and tested Master Cell Banks
  • Scaleable equipment/techniques employed 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