FrieslandCampina Domo is known as a producer of ingredients for baby food, such as protein hydrolysates. However, protein hydrolysates are also used in the biopharmaceutical industry for the latest generation of medicines. For example, for the production of the antibodies immunoglobins and of growth factors that are used for the treatment of life-threatening diseases such as cancer and haemophilia.
Hydrolysates are the product of a hydrolysis process in which natural proteins are cut into smaller pieces via a complex set of process steps. And just like the results of other natural processes, the hydrolysates also show variation. Variation that will affect the cell growth and yield of the cell culture process. But these processes also have their own influencing factors and sources of variation. The question now is: to what extent do variations in the composition of hydrolysates affect the variation in the yield of the customer's cell lines? To put it more simply: what is the effect of the raw material on the production of the end product? To find out, Domo contacted CQM.
Domo had been working on a Quality by Design (QbD) project for some time in which a lot of process data was collected and experimental work was done. CQM went back to basics and set up hypotheses and tested assumptions using a statistical approach. Because customers do not like to reveal their own process data, Domo has set up its own cell line, on which many tests have been performed. Based on these results and the data already available, we were able to draw a first conclusion: about half of the variation in the final yield is not caused by hydrolyzate.
Dominick Maes, R&D Manager Biopharma Ingredients at Domo: “We had previously had help from statistical experts, but that did not provide any further understanding of what is actually happening, apart from a number of abstract statistics. CQM works very differently, creating a kind of integration between our content and CQM's methodological knowledge. A great example of how biochemical and statistical knowledge can go together in optimal symbiosis.”
Like to know more about the effect of a raw material on the production of the end product?
Please contact Peter Stehouwer.