In the quality control of drugs such as antibodies, vaccines, cell and gene therapies, recombinant proteins, and small molecules, tests for process impurity residues, safety, or cytokine content are all included. The ELISA detection method offers advantages such as high sensitivity, high accuracy, and high throughput, enabling rapid and efficient detection of residual levels of most process impurities in biological products or cytokine content in biological products. The qPCR detection method, combined with sample pretreatment, can sensitively, efficiently, and accurately detect items related to host cell nucleic acid residues and safety.
Junyan Biotech has deep expertise in the field of biological product quality control for many years and possesses comprehensive technical platforms. For kits based on ELISA/qPCR principles, we assist clients in completing the full process of service, from antigen protein preparation and characterization/target selection (primer and probe design), antibody preparation/nucleic acid standard preparation, analytical method development and validation, large-scale production, to technical document output, to develop detection kits that meet regulatory requirements and corporate standards.
