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Our core expertise is in optimizing bioprocess to establish high yields of target protein in upstream with high purity and recovery in downstream without compromising quality. We have invested in high-performance technologies that support robust and efficient processes that are easier to scale up. We offer efficient tech transfer of developed processes that follows a structured approach with predictable outcomes. The tech transfer can be to customer’s facility or our own manufacturing facility. We offer integration of Process Analytic Tools (PAT) during process development & scale up and also offer expertise in process characterization studies using scale down models.

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Upstream Development & Scale Up

We offer process development & scale up services in microbial expression systems. We offer our experience in expressing proteins as inclusion bodies, soluble or periplasmic proteins. We have expertise in optimizing fermentation processes to establish high expression yields.

Cell & Molecular Biology

  • High throughput screening
  • Clone optimization using BLI & Western Blot
  • Cell banking and characterization
  • Cell bank storage (-80°C & Liq. N2)

Microbial

  • Media screening & optimization using DoE
  • Process development up to 20L fermenter scale
  • Process Scale up at 50L
  • End of product cell line characterization

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Downstream Development & Scale Up

We have expertise in developing high recovery purification processes for both microbial system. Our expertise includes developing processes such as chromatography, filtration, precipitation/crystallization, virus removal & inactivation. We incorporate QbD principles in purification process development. We have capabilities to handle Drug substance in both liquid and lyophilized formats from mg-to-gm scale.

Our Expertise Includes:

  • Chromatographic steps – ion exchange, size exclusion, reverse phase, affinity based-including resin screening, QbD based process optimization & establishment of scale up factors
  • Fltration operations-depth filtration, ultra-filtration, dia-filtration
  • Continuous centrifugation operation for cell harvest, inclusion bodies processing etc.
  • Development of easily scalable precipitation/crystallization techniques
  • Various protein modification techniques such as refolding, conjugation & enzymatic conversion
  • Viral removal & clarification operations such as low pH, solvent-detergent based or chemical inactivation & chromatographic based techniques

 

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Formulation Development & Scale Up

We offer our experience in developing injectable formulations in vials, prefilled syringes & cartridges.

We can carry out the following studies:

  • Excipient screening studies
  • Pre-formulation studies
  • Stability studies – at different temperature conditions as per ICH guidelines
  • Thorough analytical characterization of formulations as well as comparison studies
  • Compatibility studies

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