What are the critical problems with USP monitoring in the biopharmaceutical industry today?

 

Today monitoring is characterized by several critical limitations:

  • Not real-time: analytical quantitation obtained between 30’ and several days after sampling -> poor understanding of the process; impossible to implement a control loop on the bioreactor or on the DSP equipment
  • Not in-line: sample state may change between sampling and analysis
  • Not automatic: human intervention needed (infrequents, errors, or contamination)
  • Sampling needed

Limited in-line control of cell cultures (USP) in bioreactors can lead to:

Batch failures 2 000 L scrapped: 0.5 M€
Waste of time and money up to 6 scale-up steps from R&D to operations
Production yield not optimized +20% yield upstream with ProCellics™ = significant operational margin increase
The use of daily sampling induces a risk of contamination reject of batches with a financial impact > 10 M€
Quality control not easy to justify with regards to regulatory agencies