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Product-Related Impurity Analysis

InDuring the production process of biological products, not only process-related impurities might be generated, but also product-related impurities. The product-related impurities of biological products mainly comprise various molecular variants that are inconsistent with the functionality of the target product. The most common variants are chemically modified types of variants, degradation products, and aggregates of the target product. Various unexpected post-translational modifications (such as deamidation, acetylation, mismatched disulfide bond linkages, etc.) are significant quality issues leading to protein heterogeneity and can be detected by peptide mass fingerprinting, chromatography, electrophoresis, and other methods. Degradation products and aggregates of the target product can be detected using size-exclusion chromatography and other methods.

BTP BioScience Technology, based on dual quality certification systems CNAS/ISO9001, has established seven major testing platforms. By combining high-resolution mass spectrometry, MALDI TOF, high-performance chromatography, capillary electrophoresis, and other analytical techniques, it can efficiently and accurately analyze product-related impurities in biological products. Additionally, BTP BioScience Technology provides othercharacterization services for biological productsrelated services. Click to learn more.

BTP BioScience Technology Biological Product Characterization Services