Sowing the seeds of consistency: What to consider with plant-based pharma ingredients

In this article, Hervé Sibillat, general manager, ADM-SIO, discusses the important considerations in managing the natural variability of plant-based pharmaceutical ingredients.

Sowing seeds

Variations in the composition and physicochemical properties of pharmaceutical ingredients can have a significant impact on the safety and performance of the final drug product. A failure to properly manage the process has been the root cause of several recent recalls by the US Food & Drug Administration (FDA). Indeed, ‘variability reduction’ is identified as a key objective of the ICH Q10 Pharmaceutical Quality System.