BioStreamline

The BioStreamline project brings a unique approach to mitigating biotherapeutic development challenges using state of the art technologies to provide developers with a better understanding of candidate molecules earlier in the development process. This should allow developers to make better informed development decisions about which molecules to progress in development — reducing risk, cost and time.

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The Challenge

CPI was involved from the conception of the project through planning, partner selection and delivery. The challenge being addressed is that the biopharmaceutical industry has badly needed a more efficient supply chain that enables it to make predictions about the problems associated with developing new biotherapeutics reducing the risk and cost of commercialisation.

Inputs

  • Provided open access to CPI’s state-of-the-art facilities
  • Shared expert technical and industry knowledge
  • Provided project management and business support services for publicly funded R&D projects

Outputs

  • Development of a new single cell analysis system (Cyto-Mine®)
  • New approaches to cell line development using CRISPR allowing rational inclusion of specific cell line features 
  • Developability data (biochemical, biophysical, stability) from a defined panel of 50+ mAb (selected from a panel of 200+ mAb sequences) and generation of decisional tool
  • Investigation of easy to implement, preclinical assessment of immunogenicity risks

Outcomes

  • Decisional tool to support molecule development assessment
  • New products and approaches available for shortening cell line development
  • Database of molecule information for developability assessment and further investigation by advanced data analytics
  • Exemplification of collaborative project approach which would be applicable to other therapeutic modalities including viral vectors

How CPI helped

As well as managing the project CPI inputs involved use of their expertise and facilities to generate samples of the 50+ shortlisted panel of monoclonal antibodies, generation of biochemical, biophysical and stability data on the molecules as well as data analysis.

Summary

CPI played a key role in this project through use of their state of the art facilities and expert knowledge. Learning from the project will help create a shorter and more agile timeline in biologics development. Follow on projects at the concept stage would potentially involve application of advanced data management or to the supply chain for other modalities including viral vectors.