Process Development

We help you get the process right, the first time.

The goal of any process development scientist is to end with a robust, scalable process that will ensure consistent, high-quality product with reduced risk and acceptable cost of goods – all while meeting tight timelines. The ability to achieve this delicate balance comes with experience, which we share with you during the development of pre-clinical and clinical cell therapy processes to help you reach the therapeutic promise of your candidate.

The Approach

Designing the process with manufacturability in mind is critical. We start with a wide process characterization lens, beginning with the Critical Quality Attributes (CQA’s). Then, by establishing Critical Process Parameters (CPP’s), we can thoughtfully design your process while considering scalability and media optimization strategies.

Setting the Criteria

  • Understand CQA’s
  • Establish CPP’s
  • Product specifications

Design for the Right Scalability

  • Scale out / scale up
  • 2D or 3D cell culture
  • Closing up the process

Reagent Optimization

  • Risk mitigation
  • Feeding strategies
  • QbD / DOE Studies

Develop/Optimize the Process

  • Cell isolation/enrichment
  • Cell modification and expansion
  • Cell transfection/transduction

Process Development

Do you have an existing manual process that would benefit from automation? Perhaps an open culture system that you wish to be functionally closed? Limited procedures? Let Theragent’s Process Development team design and improve your process to set your future manufacturing up for success. Drawing upon our collective past of developing programs for T-cells, NK cells, iPSC’s, and more, leverage our process science know-how to provide you with a more robust process using modern tools and the latest media and reagents.

Additionally, our process development team is co-located with our analytical development group, so we can provide the best analytical tools for your cell type in a cohesive manner.

Learn more about our analytical
development services…