Dr Kevin Robinson (KSR) spoke to CEO Hanns-Christian Mahler (HCM) and Ivana Heckel (IH), Director of Quality Control, to find out more.
“The integration of formulation and process development with manufacturing (fill-finish) and testing (quality controls) combines all the elements of quality-by-design,” says Hanns-Christian.
“This holistic approach allows the systematic development and commercialisation of a sterile drug product in the most effective manner.” As an example, he explains, an appropriately developed sterile medicine will have a reduced risk of major issues during manufacturing.
“Appropriate development also facilitates better CQA (critical quality attribute) assessments. And having a combined quality control (QC) and manufacturing setup ensures adequate definition of the control strategy — from incoming material analysis to in-process-control and final product testing.
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