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Kai Touw

Kai Touw
Kai Touw is a (Bio)Pharma Market Manager at Sartorius Stedim Data Analytics. He is a driven and enthusiastic technology evangelist bridging the world of data science into pharmaceutical and biopharmaceutical processing.
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Recent Posts

Which data analytics methods best support a quality by design approach for biosimilars?

November 12, 2019

Biosimilars are an exciting route to increasing access to the highly effective therapy made possible by biologics, but ensuring a biosimilar meets the critical quality attributes (CQA) of the original biologic is a major challenge. Optimizing production at full scale is impractical, which makes a quality by design (QbD) approach using a reliable scale down model of the process an attractive alternative. A process development team at Zhejiang Hisun Pharmaceuticals, Taizhou, China, therefore developed a scaled down model of the cell culture process used to produce the biosimilar adalimumab. They qualified the model using multivariate data analysis (SIMCA), and explored the design space for key process attributes (KPA) and CQAs using MODDE.

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The trending role of artificial intelligence in the pharmaceutical industry

September 26, 2019

Over the last several years, the use of artificial intelligence (AI) in the pharma and biomedical industry has gone from science fiction to science fact. Increasingly, pharma and biotech companies are adopting more efficient, automated processes that incorporate data-driven decisions and use predictive analytics tools. The next evolution of this approach to advanced data analytics incorporates artificial intelligence and machine learning.

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Interpretation for the use of multivariate models within the FDA draft guidelines for continuous manufacturing

April 24, 2019

Recently the FDA issued a new draft guideline for continuous manufacturing of small molecule drugs. With these draft guidelines the FDA wants to engage more pharmaceutical manufacturers to shift from traditional batch/start-stop processing to continuous manufacturing. The main advantages associated with these processes are more room for modularity, automation and flexibility due to a smaller footprint, but also more consistent quality of the drug product. Of course the main incentive for the FDA to promote this way of processing is that it believes that this will have a positive impact on drug prices and prevent drug shortages.

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Using advanced data analytics to make the shift to continuous process manufacturing

April 2, 2019

Throughout the evolution of manufacturing, many industries have gradually shifted away from batch process to continuous process manufacturing as production technologies matured. This has included industries such as chemical, petroleum, steel, automobile, consumer goods and food manufacturing.

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