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Process Development & Scale-Up

Designed to de-risk your project with best-in-class technologies for smooth scale-up and technology transfer through process optimization and characterization.

 

A true partnership to take your product through the full lifecycle, we can cater for both drug substance and drug product requirements from development, into clinical and commercial manufacture. Our integrated offering means we can progress your product to market in a cost-efficient way.

Our team collaborates with you to optimize your process, achieving and increased yields of your target protein in upstream manufacturing with high purity and recovery downstream without compromising quality.

We have invested in high-performance technologies and integrated Process Analytical Tools (PAT) -this combined with our expertise in process characterization studies using scale down models ensures robust and efficient processes that facilitate simpler scale up. Reliable tech transfer of developed processes following an established approach can be delivered at your site or into our own manufacturing facility.

 

 

 

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Upstream Development & Scale Up

Our expertise lies in developing and transferring high-yielding manufacturing-ready processes for both microbial and mammalian expression systems, with a laser focus on process robustness, scalability, economic viability and compliance with regulatory requirements.

Mammalian

We can provide process optimization, scale-up and tech transfer of mammalian-based processes to produce monoclonal antibodies, glycoproteins, complex fusion proteins and other recombinant proteins.

Our team has significant experience in developing and scaling up high-yielding processes, with a focus on improving speed to clinic or market and reducing costs.

Services:

  • Clone development and high throughput screening of high producer clones
  • Cell banking, storage and characterization, including master, working and end-of-production cell banks
  • Cell culture process optimization by media, feed screening & parameter optimization using DoE methodology.
  • Process development up to 2-5L bioreactor scale
  • Process scale up to non-GMP 200L SUB scale
  • Manufacturing ability for clinical study or commercial under CGMP conditions up to 2000L scale
  • Process characterization studies to support late-stage development, process performance qualification and regulatory submissions
  • Process improvement studies to improve the overall yield of the process

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Microbial

We provide strain development, process optimization, scale-up and tech transfer for microbial systems to produce recombinant proteins, antibody fragments and other novel scaffolds.

We have significant experience in expressing proteins as inclusion bodies, soluble or periplasmic proteins and optimizing fermentation processes to establish high expression yields.

Services:

  • Molecular biology, vector construction and strain development by high throughput screening
  • Production strain finalization and optimization of fermentation processes based on DOE studies
  • Media development and optimization
  • Feed development
  • Cell banking and characterization, including master, working cell bank and end of production cell banks
  • Cell bank storage (-80°C & Liq. N2)
  • Fermentation process optimization by media screening & parameter optimization using DoE methodology
  • Process development up to 20L fermenter scale
  • Process characterization studies to support late-stage development, process performance qualification and regulatory submissions
  • Process scale-up at 50L scale with the capability to generate material for pre-clinical, animal efficacy and toxicology studies
  • Manufacturing ability for clinical study under GMP conditions up to 1000L fermentation scale

 

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Downstream Development & Scale Up

With expertise in developing high recovery purification processes for both microbial and mammalian systems, we can develop processes such as chromatography, filtration, precipitation/crystallization, virus removal and inactivation.

We incorporate QbD principles in purification process development and have capabilities to handle drug substance in both liquid and lyophilized formats from mg-to-gm scale Developed process are highly robust and scalable which helps in transferring the technology to any business partner and scaling it to desired manufacturing scale

Services:

  • QbD based development, optimization and scale-up of chromatographic steps – ion exchange, mixed mode, size exclusion, reverse phase, affinity based-including resin screening
  • Screening, optimization and scale-up of filtration operations-depth filtration, ultra-filtration, diafiltration
  • Continuous centrifugation operation for cell harvest, inclusion bodies processing
  • Development of easily scalable precipitation/crystallization techniques
  • Various protein modification techniques such as refolding, conjugation and enzymatic conversion
  • Viral removal and clarification operations such as low pH, solvent-detergent-based or chemical inactivation, virus filtration, and chromatographic-based techniques
  • Impurity isolation and purification for process characterization or other clinical studies
  • Process scale-down model development and process characterization studies

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Formulation Development & Scale Up

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

Services:

  • Drug product non-infringing formulation development, including excipient and buffer screening and selection studies
  • Drug product process development to design manufacturing process unit operations and operating parameters
  • Stability studies – real-time, accelerated and stress, and photostability as per ICH guidelines
  • Thorough analytical characterization of formulations as well as comparison studies
  • Container closure and other compatibility studies
  • Development of lyophilization cycles for final formulated product

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A dedicated team driven to deliver your biologic project on time and on budget.

Find out how we can de-risk your projects from start to finish.