Biopharmaceuticals contain residual host cell protein (HCP) impurities, a complex mixture of endogenous proteins from production cell lines such as Chinese hamster ovary (CHO) cells. The composition of HCP impurities at harvest hinges on multiple factors, e.g., identity of cell line, cell density and viability at harvest, or other process parameters. Two-dimensional differential gel electrophoresis (2-D DIGE) was used to compare HCP in 15 null cell culture harvest supernatants, which are representative for a wide range of manufacturing processes of therapeutic antibodies, using five different CHO cell lines. Numerical metrics were developed to quantitatively compare HCP composition, which may be used to assess the suitability of a platform HCP assay standard for a new product or to assess the impact of process changes. A very similar HCP composition was found for the 15 analyzed CHO null cell culture harvests, demonstrating that even the wide range of applied manufacturing processes did not have a strong influence on the HCP impurities.
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Quantitative proteomic analysis of residual host cell protein retention across adeno-associated virus affinity chromatography.
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Article Synopsis
- Ademetionine 1,4-Butanedisulfonate (SAMe) is a drug used for treating liver disease, depression, and Alzheimer's, primarily produced via fermentation processes, which can lead to contamination from host cell proteins (HCP).
- HCP poses risks like allergic reactions and affects the drug's quality and safety, with ELISA and mass spectrometry being common methods for measuring these impurities.
- A study evaluated SAMe from two suppliers, finding low levels of HCP and SAMS residues, while also highlighting the need for effective evaluation of impurities in active pharmaceutical ingredients (API).
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