Process-Development

Core Services

  • Clone screening and selection
  • Media and cell culture optimization
  • PD / preclinical manufacturing capabilities at 5L, 10L and 80L scale

Kemwell’s biopharmaceutical labs have the capability of performing complete process development, process optimization, scale-up, technology transfer and process characterization. Moreover, our scientists have demonstrated the capability to design and execute development work to meet defined product quality attributes. Kemwell’s integrated cross-functional project teams comprise of process and analytical development scientists who work closely together leading to excellent product and process understanding.

Upstream Development

  • Mammalian cell culture process development for recombinant proteins and monoclonal antibodies
  • Experienced development scientists who understand the complex dependence of cell culture parameters on product quality attributes
  • Well-equipped labs to perform process development and process characterization studies

Critical Equipment List +

  • Biosafety cabinets and Laminar Air Flow Units for aseptic work
  • Access controlled cell bank (research cell banks and working cell banks) storage facility
  • CO2 incubators for shake flask experiments
  • Bioreactors
    • 5L and 10L glass bioreactors
    • 80L SS bioreactor
    • WAVE bioreactor™
  • Metabolite analyzer
  • Cell viability analyzer
  • Perfusion (provision for addition)

Downstream Development

  • Purification process development for recombinant therapeutic proteins and monoclonal antibodies
  • Well-designed purification process schemes with clearly established capabilities for each process step
  • Close collaboration with analytical method development scientists to develop in-process testing schemes

Critical Equipment List +

  • AKTA purifierTM
  • AKTA pilotTM
  • Cogent TFF systems
  • Milistak+Pod filtration system

Process Characterization

  • Establishment of scale-down models
  • Univariate and multivariate DoE studies
  • Studies to define critical and key process parameters, establishment of design space, etc.
  • Control strategy