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Upstream process development

Providing expertise in cell culture and upstream process development for biologics

At Thermo Fisher Scientific, we offer a comprehensive suite of upstream process development services to help accelerate your biologics journey from discovery to clinical commercialization without compromising quality, while minimizing risk. With over 30 years of experience across more than 200 molecules, we specialize in the development of monoclonal antibodies (mAbs), bispecific antibodies, Fc fusion, enzymes, recombinant proteins, and many other complex molecules. Our end-to-end upstream capabilities are designed to address your unique challenges, to help accelerate your path to market, and to deliver robust, scalable, and tailored production solutions.


Technical expertise

Our expertise in fed-batch and perfusion culture systems with media screening tools helps to ensure tailored solutions that optimize cell growth, nutrient delivery, and culture conditions to produce any recombinant protein, even with the most challenging characteristics. 

High protein yield

Our process development experts leverage advanced bioreactor platforms, customized media formulations, and cutting-edge control strategies to maximize yields while maintaining consistent drug substance quality.

Accelerated time-to-market

With cutting-edge technology, including the Ambr™ 15 and Ambr™ 250 systems, we can maintain precise control over cell culture development and scale-up, maintaining a reliable platform and helping to accelerate timelines. 

Upstream process development services

  • Clone and media/feed screening, process development/optimization using the Ambr 250 system 
  • Master cell banking 
  • Fed-batch, perfusion, and XD™ cell culture process
  • Use of high-density mammalian cell culture technologies, including proprietary XD™ technology 
  • Cell culture process modeling, metabolite, and amino acid analysis
  • Single-use scale-up and scale-down models 
  • Upstream process intensification
  • Technology transfer 
  • 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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