Introduction:
Current biopharmaceutical potency testing methods are time-consuming, labor-intensive, and can pose a risk of contamination. In a new study, researchers at Bayer Pharmaceuticals in California propose a software-based alternative to streamline potency testing and improve efficiency.
- Biopharmaceutical manufacturers regularly test the potency of samples taken from the production line to ensure products meet defined potency specifications.
- Current potency testing methods are challenging to carry out and require manual calculations, which are error-prone and time-consuming.
- The Bayer team has developed a cloud-based software application that automates data acquisition, pre-processing, statistical calculations, visualization, and reporting.
- The software serves as a “digital assistant” to help experts evaluate potency targets in sterile fill-finish processes, linking out-of-spec results to specific process parameters.
- The application has resulted in a reduction of effort and time required for potency assessments, improving efficiency, consistency, and accuracy.
Conclusion:
The software-based alternative for potency testing proposed by the Bayer team offers potential improvements to current methods, streamlining the process and reducing the risk of contamination. The automation of data analysis and the ability to link out-of-spec results to process parameters can enhance efficiency, consistency, and accuracy in potency testing. This approach could be applied more widely to evaluate other critical quality attributes in biopharmaceutical manufacturing.
