Process Development and Scale Up

 

Our core expertise is in optimizing bioprocess to establish high yields of target protein in upstream and 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 Analytical Tools (PAT) during process development & scale up and also offer expertise in process characterization studies using scale down models.

Process Development and Scale Up
 
 

UPSTREAM Development & SCALE UP

We offer process development & scale up services in both microbial & mammalian expression systems. In microbial, 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
  • Stability analysis of selected clones
  • Cell bank storage (-80°C & Liq. N2)
  • MAMMALIAN

  • Media screening & optimization with micro-bioreactor using DoE principles
  • Spent media analysis for understanding of cell culture behaviour
  • Process development up to 10L scale & scale up to 200L using single use bioreactor
  • MICROBIAL

  • Media screening & optimization using DoE principles
  • Process development up to 20L fermenter scale & scale up at 50L scale
  • Scale up supported by continuous disc stack centrifuge & high pressure homogenizer
  • End of product cell line characterization
  • UPSTREAM Development & SCALE UP
  • UPSTREAM Development & SCALE UP
  • UPSTREAM Development & SCALE UP
 

DOWNSTREAM Development & SCALE UP

We have expertise in developing high recovery purification processes for both microbial & mammalian systems. Our expertise includes developing processes such as chromatography, filtration, precipitation/crystallization, virus removal & inactivation. We incorporate DoE principles in purification process development. We can generate final 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, DoE 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
 
  • DOWNSTREAM Development & SCALE UP
  • DOWNSTREAM Development & SCALE UP
  • DOWNSTREAM Development & SCALE UP
 

FORMULATION Development & SCALE UP

We offer our experience in developing injectable formulations in vials, prefilled syringes & cartridges. We can supply material from our scale-up facility for animal toxicity and efficacy studies.

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

 
  • Formulation Development & Scale up
  • Formulation Development & Scale up
Process Development and Scale Up