Good Manufacturing Practice compliant change of raw material in the manufacturing process of a clinically used advanced therapy medicinal product a comparability study

The development of medicinal products often continues throughout the different phases of a clinical study and may require challenging changes in raw and starting materials at later stages. Comparability between the product properties pre- and post-change thus needs to be ensured. The increased risk for tumorigenicity potentially associated with the use of human platelet lysate was assessed through karyotyping of chondrocytes at passage 4, revealing no chromosomal changes.

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