Trypsin is a serine protease that specifically recognizes and cleaves the arginine-lysine (Arg-Lys) peptide bonds in adhesion proteins on the cell surface. It plays a critical role in cell-based vaccine production and gene therapy cell culture, and is widely used to dissociate adherent cells such as HEK293 and Vero, enabling their efficient separation from the surface of culture vessels.

However, residual recombinant trypsin in the final product may not only affect process efficiency and product integrity, but also pose potential safety risks. In response to this, the?Chinese Pharmacopoeia (2025)?has established clear regulatory requirements:

·?In the general chapter of biological products,?Quality Control of Raw Materials and Excipients for Biological Product Production, protein hydrolases of non-animal origin are classified as medium-risk raw materials;

·?Meanwhile, the?General Principles for Human Gene Therapy Products?stipulates that potential process-related impurities shall be identified, evaluated, and subject to qualitative and/or quantitative analysis.

To accurately monitor and control this critical residual impurity, Cygnus Technologies has launched a new rTrypsin ELISA Detection Kit. Based on the sandwich ELISA principle, this kit features simple operation. During its development, antibodies were prepared using recombinant porcine trypsin and subjected to strict antigen-affinity purification—ensuring high specificity of the antibodies for the target molecule. As such, this kit serves as an ideal process development tool: it can be used to optimize the removal efficiency of recombinant trypsin, as well as for routine quality control and product release testing, helping products meet regulatory requirements.

Product Performance

·?Ultra-High Sensitivity: Limit of Detection (LOD) ~0.05 ng/mL; Limit of Quantitation (LOQ) ~0.31 ng/mL

·?Excellent Precision: Intra-assay and Inter-assay CVs (Coefficients of Variation) are both < 10%

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·?Accelerate the R&D phase

·?Enhance drug quality, purity, and safety

·?Speed up the optimization of R&D processes

·?Shorten time-to-market for products

·?Reduce QC (Quality Control) costs

If you are interested in the aforementioned products, please feel free to:

·?Call XMJ’s customer service hotline:?400-050-4006

·?Visit the official website:?www.gp82.cn?for more information.