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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

Get in touch

Microbial

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

Get in touch