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Bioprocess monitoring and end-product lyophilization

Biopharmaceuticals (including e.g. recombinant proteins, monoclonal antibodies, and nucleic acid based medicines) are increasingly entering the market. In 2005, it was estimated that already one out of four new pharmaceuticals came from biotechnological production process.

The complexity of biopharmaceuticals leads to far more challenging manufacture and storage schemes than with traditional small molecule pharmaceuticals. The concept of providing monitoring, analysis and storage systems for demanding bioprocesses is feasible considering the increasing number of biomedical products. Along with valid tools for monitoring the production processes, developing stable forms of biomedicines with extended shelf lives is crucial in making the lifecycle of these products more cost-efficient and environmentally sustainable.

Bioprocess monitoring and end product lyophilization (also known as freeze-drying) sub-project aims at:

  1. extending biopharmaceutical product life cycle by generating new solid formulations by lyophilization and other techniques.
  2. enhancing production of biopharmaceuticals by developing in-line process monitoring tools according to PAT guideline.


 
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Promis centre University of Eastern Finland VTT Savonia University of applied sciences