Detection And Quantification Of Process-Related Impurities In Biopharma Manufacturing

By Jai Kumar Keshwan, Associate Research Director, Analytical Research Development, Syngene International Ltd.

Process-related impurities can significantly impact a pharmaceutical or biopharmaceutical product’s quality, safety, and efficacy, making detection and quantitation of process-related impurities an important part of quality control in the manufacturing process. These impurities may get generated due to the manufacturing process, degradation, starting materials and reagents, byproducts, storage conditions, or contamination, and if not properly detected and quantified, can lead to adverse effects on patients.

Utilizing a framework to identify the critical quality attributes (CQAs) and finalize the relevant process parameters during product development is a key step in properly detecting and quantifying process-related impurities.

Finding a partner with the expertise and capabilities, including state-of-the-art instrumentation, to provide comprehensive solutions for the detection and quantitation of process-related impurities in pharma and biopharma products can aid in accurate identification, even at low levels. This ensures the successful development and manufacturing of safe and effective pharmaceutical and biopharmaceutical products at all times.