Understanding variation at FrieslandCampina Domo

FrieslandCampina Domo is known as a producer of ingredients for baby food, such as protein hydrolysates. But protein hydrolysates are also used in the biopharmaceutical industry for the latest generation of medicines. For example, for the production of immunoglobulin antibodies and growth factors that are used to treat life-threatening diseases such as cancer and hemophilia.

Variation

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 outcomes of other natural processes, the hydrolysates also show variation. Variation that will impact cell growth and yield from 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 influence the variation in the yield of the customer's cell lines? More easily said: what is the effect of the raw material on the production of the final product? To find out, Domo contacted CQM.

Statistical approach

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 carried out. Based on these results and the data already available, we have been able to draw a first conclusion: approximately half of the variation in the final yield is not caused by hydrolyzate.

Optimal symbiosis

Dominick Maes, R&D Manager Biopharma Ingredients at Domo: "We have previously had help from statistical experts, but apart from a lot of abstract statistics, that did not provide any further understanding of what is happening in reality. CQM works very differently, which creates a kind of integration between our substantive and CQM's methodological knowledge. A good example of how biochemical and statistical knowledge can go together in optimal symbiosis."

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Photo credits: CQM and Friesland Campina Domo.}