An indirect ELISA method was developed and validated for quantifying HuB01 in fermentation products, demonstrating a lower limit of quantification of 3.906 ng/mL.
An indirect ELISA method was successfully developed and validated for the accurate quantification of HuB01 in fermentation products.
BACKGROUND: The antibodies (including 7C4, 8D1) are neutralizing antibodies specifically targeting the protein RBD, a key core of the combination with angiotensin-converting enzyme 2 (ACE2). In order to measure HuB01 in fermentation products accurately, a bioanalytical method was needed, which should have high selectivity and be free from interference by 501Y.V2. METHODS AND RESULTS: To quantify HuB01 in fermentation products, an indirect ELISA was developed and validated, utilizing anti-idiotypic monoclonal antibodies for both capture and detection. The assay demonstrates high sensitivity, with a lower limit of quantification set at 3.906 ng/mL, a wide dynamic range spanning 3906-125 ng/mL for HuB01, and outstanding precision and accuracy. CONCLUSION: A sensitive and selective method for measuring HuB01 in fermentation products has been developed and validated by us. Currently, this assay is applied in the quality control of the production process.
Liu et al. (Fri,) reported a other. Indirect ELISA method was evaluated on Quantification of HuB01 in fermentation products. An indirect ELISA method was developed and validated for quantifying HuB01 in fermentation products, demonstrating a lower limit of quantification of 3.906 ng/mL.