Cell Culture Process Development

As a leader in the field of immunotherapy, Creative Biolabs has gained extensive experience developing mammalian and microbial production cell lines. The discovery experience companied with our advanced analytical capabilities enables us to identify and select clones that meet your product’s specific parameters and characteristics. After selecting the most appropriate clones, we optimize cell culture conditions to develop a high productivity cell line tailored to your specific product quality targets and desired productivity level, which is designed for robust, scalable manufacturing.

Our Cell Culture Development Services

With powerful team of over 100 dedicated and skillful scientists and technicians, Creative Biolabs offers state-of-the-art cell culture development services to enable clone screening and selection, media optimization, seeding density, feeding and bioreactor process control relevant strategies. Our cell culture development platform is dedicated to maximizing the expression, enhancing process reproducibility and facilitating the future scale-up process. To ensure our cell culture development highly professional, we are equipped with a wide range of cell culture systems as well as advanced testing technologies including:

  • Bioreactors ranging from 1L to 2000L,
  • GMP and non-GMP manufacturing,
  • Wave and rocker based bioreactors,
  • Cell culture analyzers including Vi-cell, multiple microscopes, YSI, Cedex Bio HT, Novaflex, Bioprofile 400, BGA, Terumo tubing welder, Osmometer, Sterile tubing welder and sealer, Integrity tester, Media prep systems for lab & pilot plant, etc.

Our advanced platform enables us to perform more than 30 simultaneous development projects at different development stages. We offer maximum flexibility to ensure your project to be initiated at any stage of development. Here are some examples of our cell culture development support for your reference. Any other requirements, please feel free to let us know.

Standalone projects

  • Culture media screening and adaptation,
  • Material preparation for different stages of projects, such as transient and pool material production,
  • Various bioreactors available,
  • productivity and/or quality optimization.

Late stage cell culture process development

  • Technical transfer,
  • Commercial process development service,
  • Process characterization and validation.

IND-enabling cell culture activities

  • Clone selection and process optimization,
  • Scale-up and toxicological material production,
  • Technical transfer for cGMP production for worldwide IND submissions.

Perfusion and concentrated fed-batch platform

  • High viable cell density and viability,
  • For perfusion: long term steady-state operation and stable productivity and quality,
  • For concentrated fed-batch: quick adoption from fed-batch with high harvest product titer and improved quality,
  • From bench top scale-down model to cGMP manufacturing production.

Expression Platform

We have developed a series of proprietary expression systems. These robust and scalable expression platforms have been used extensively to create many production cell lines. It accelerates development of cell lines for further production by using robust procedures and chemically defined media and feeds, to produce high levels of recombinant protein with a short timeline.

Product Quality Optimization

To optimize various product quality attributes, we have established a comprehensive series of approaches including, but not limited to.

  • Aggregation control,
  • Charge variant control,
  • Glycosylation optimization,
  • Sialic acid content optimization,
  • ADCC/CDC activity optimization .

Each step in the upstream process impacts the quality, purity, and quantity of the manufactured protein. At Creative Biolabs, we have developed various mammal -, bacteria and yeast-based cell culture developments in the last decade, giving us the insight necessary to identify and optimize upstream parameters that are critical for achieving a high-quality, cost-effective biomanufacturing process. Please contact us for more information and a detailed quote.

For lab research only, cannot be used for any clinical use.

Online Inquiry

Verification code
Click image to refresh the verification code.
Copyright © 2007 - 2021 Creative Biolabs. All Rights Reserved.