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Process Development and R&D

The Process Development and R&D team offers expertise and services to support the development of ATMP from early R&D stages to GMP-readiness.

Our mission:
  • Your success: fully committed to helping you to achieve your aims in the most efficient way and to the highest quality. Your success is our success.

  • Your satisfaction: determined to provide you with the best end-to-end customer experience through tailored support, clear communication and the personal touch. We are on your side.
     

Our team:
  • A highly competent, friendly and passionate group of scientists, with a broad range of scientific and technical skills to help you develop your cell therapy product

  • 86% hold a Master degree or above, 40% hold a PhD

  • Expertise in a broad range of disciplines including:

    • Cell and gene therapy - 25 years of experience in cell therapy

    • Cellular, molecular and developmental biology (Including iPSC)

    • Immunology

    • Statistical analysis

    • QbD and PAT principles

    • Project management

    • Scientific writing

Our services

From concept to bench top, our team can help you with:
 

R&D:
  • Consultancy, strategic advice, project evaluation, gap analysis

  • In vitro proof of concept, mode of action, feasibility studies
     

From bench top to clinical manufacturing, our team can help you with:

Analytical development:
  • Product characterisation, phenotyping and functional assays, cell-based assay, biochemical assays

  • Assay design, development and optimisation, GMP-readiness, technical transfers to Quality Control
     

Process development:
  • Process design, development, optimisation and monitoring, GMP-readiness, technical transfers to Production

  • Process and product characterisation, identification of CQA, CMA and CPP, scale-up, scale-out, automation

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