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Downstream process development

Providing expertise in downstream process development for biologics

Downstream process development comes with unique challenges, especially when transitioning from benchtop to GMP production and manufacturing. With over 30 years of experience developing purification techniques for complex molecules, Thermo Fisher Scientific’s end-to-end downstream capabilities, open analytical testing, and seamless technology transfer are designed to minimize risk and overcome these challenges to help accelerate your path to market, while delivering high-yield tailored solutions, without sacrificing quality.


Technical expertise

Our team of experts have specialized knowledge and advanced tools to develop high concentration upstream and downstream formulations, as well as optimize purification steps to help ensure high product quality, purity, and process efficiency. 

Robust and reliable platforms

Automated, high-throughput process development utilizing Tecan™ liquid handler with robocolumns, and the ÄKTA™ liquid chromatography system to help ensure precise and reproducible protein purification.

Accelerated time-to-market

Our extensive experience in scaling downstream processes coupled with established methodologies and infrastructure support allow us to navigate potential scale-up challenges, avoid pitfalls, and seamlessly technology transfer from development to manufacturing. 

Downstream processing workflow

  • Design of experimentation (DoE)
  • Process development, transfer, and optimization
  • Scale-up from benchtop to commercial scale
  • Chromatography—pilot and benchtop scale
  • High-throughput screening and filtration
  • Open lab analytical testing
  • Material generation for studies
  • Viral clearance studies
  • Process characterization and validation studies
  • Process robustness studies

Explore our state-of-the-art global network of biologics manufacturing facilities, where innovation meets precision to produce life-changing therapies

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