EN
In the biopharmaceutical industry, host cells (such as bacteria, yeast, mammalian, insect, or plant cells) are often utilized to produce recombinant proteins, antibodies, vaccines, and other biological drugs. Impurity proteins that result from cell secretion, stress, lysis, and purification processes are known as host cell proteins (HCPs). Residual HCPs in drug products can be immunogenic and may affect the drug’s quality, safety, and efficacy. Therefore, it is crucial to establish a scientific and reliable method to measure HCP concentrations in finished or intermediate products during downstream purification development.
Enzyme-linked immunosorbent assay (ELISA), a highly sensitive and simple-to-operate technique, is widely used for detecting residual E.coli host cell proteins.
ELISA (Enzyme-Linked Immunosorbent Assay) is an immunological detection method based on the specific interaction between antigens and antibodies. It includes techniques such as the sandwich assay, indirect assay, and competitive assay. By conjugating enzymes with specific antibodies or antigens, ELISA enables the high-sensitivity detection of target molecules.
In biopharmaceutical applications, ELISA is commonly used to detect host cell proteins in cell culture supernatants, fermentation broths, or purified samples to ensure drug product safety and purity.
酶联免疫检测原理
01
Immunogenicity
Host cell proteins are a complex mixture with various physicochemical and immunological properties. They may trigger innate immune responses mediated by Toll-like receptors or directly stimulate histamine release via cytokines produced by host cells, leading to inflammation. Nearly all HCPs carry clinical safety risks as foreign proteins in drug products.
02
Adjuvant-like Effects
HCPs may act as adjuvants, enhancing the immune response to therapeutic proteins and leading to the production of anti-drug antibodies (ADA), which can directly impact the drug’s biodistribution, pharmacokinetics, and bioactivity.
03
Impact on Product Stability
HCPs may have protease or “accessory enzyme” activity, which can reduce product stability and alter efficacy. Their biological activity may also affect the drug’s pharmacological effects.
United States Pharmacopeia (USP)
Chinese Pharmacopeia
As a mature and reliable detection technology, ELISA plays an important role in detecting E.coli host cell proteins. Through carefully designed experimental protocols and the selection of specific antibodies, ELISA contributes to improving the quality of biopharmaceutical products and ensuring patient safety. In the future, with continued advancements in biotechnology, ELISA is expected to expand its applications across various fields, further contributing to human health.
References:
[1]. USP <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals
[2]. "Chinese Pharmacopeia" (2020 Edition): 9012 Guidelines for Quantitative Analysis of Biological Samples
[3]. GB/T 33411-2016 General Specifications for ELISA Kits
[4]. YY/T 1183-2010 ELISA Detection Kits
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