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process_development

 

Kemwell provides extensive mammalian cell culture-based products’ development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology transfers, 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 comprised of the process and analytical development scientists who work closely together leading to excellent product and process understanding.

Each customer project is individually customized to match the customer’s requirements as per the scope. 

Kemwell routinely provides the following development services :

  •      Upstream and Downstream Process Development
  •      Analytical methods and formulation development (including lyophilized formulations)
  •      Clone screening and selection
  •      Cell line stability studies
  •      Media and cell culture optimization
  •      Optimizing mfg. processes to improve process time and increase yields/outputs
  •      Achieving efficient process scale-up
  •      Reducing of manufacturing costs and time – through process improvements 
  •      Process characterization

                   I. Establishment of scale-down models

                  II. Univariate and multivariate DoE studies

                 III. Studies to define critical and key process parameters, the establishment of design space, etc.

                 IV. Control strategy

  •      Head to head comparability studies of biosimilars
  •      Development stability studies
  •      Preclinical manufacturing capabilities at 5L, 10L and 80L scale

Upstream Process Development

Kemwell’s team of experienced scientists and analysts specialize in mammalian cell culture process development. We use well-versed techniques such as design-of-experiments approach for process optimization to reach optimal titer values and generate superior quality products. We strive to develop a robust, efficient, scaled up manufacturing process to deliver consistent product quality.

Downstream Process Development

Kemwell’s purification process development team develops robust, economical processes for mammalian cell culture products. The design-of-experiments approach for process optimization and process characterization is used in order to achieve optimal yields. Our foremost goal is product quality and we strive to generate superior quality products. Close collaboration with analytical method development scientists ensures in-process testing scheme development.

• 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™
        ◦ ATF-2 perfusion
    • CEDEX bioanalyzer
    • Cell viability analyzer
    • AKTA purifierTM
    • AKTA pilotTM
    • Cogent TFF systems
    • Milistak+Pod filtration system

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