Process Design & Development

Innovating Efficiencies, Engineering Excellence

Strategic advancement in process development is paramount for achieving success in scaling up and clinically advancing a cell therapy product. This entails fine-tuning the manufacturing process to align with rigorous regulatory standards, thereby guaranteeing the therapy’s safety and efficacy.

Key facets of this process involve meticulous selection of appropriate starting materials, formulation of robust and scalable manufacturing protocols, rigorous implementation of quality control testing, and strict adherence to Good Manufacturing Practice regulations.

Our distinctive advantage stems from our capacity to guide and collaborate with our partners seamlessly, spanning the initial phases of pre-clinical research to the pivotal first-in-human clinical trials. Our dedicated in-house team of experts provides unwavering support at every stage, ensuring a continuum of consistency and excellence.

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Lab technician works with samples

Process Development

  • Developing protocols
  • Optimizing cell isolation, activation, transduction, expansion, harvest, and fill/finish
  • Developing scalable and reproducible manufacturing processes
  • Managing materials, supply chain, and logistics
  • Developing and implementing automation and closed-system processing where applicable
  • Scaleup and tech transfer

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