Speciality Coagulation Enzyme Assays
When it comes to the manufacturing of biologics, including heparin, rigorous quality control is essential to ensure the safety and efficacy of the final product. Heparin ELISA kits play a critical role in this process, providing manufacturers with a reliable and efficient method for performing lot release testing and assessing product quality.
Krishgen is currently the only company in the world to have the complete range of coagulation enzyme assay kits. The quantitative determination of enzymatic levels by the measurement of their anti-Xa and IIa activity is a necessary tool for monitoring treatment efficacy. These Chromogenic assays offer a more specific measurement of heparin activity, with higher accuracy and precision. They can be used to measure heparin activity and can detect low concentrations of heparin in biological samples with less interference from other substances.
Our current range of assays for coagulation studies has some of the most unique, specific assays in the world. KRISHZYME Chromogenic Assays for Factor IIa and Factor Xa are validated as per IP/EP/USP. These Heparin ELISA kits allow assessment of heparin content in raw materials, intermediates, and final batches, ensuring that they meet the prescribed specifications. These assays can quantitatively estimate the following Heparins in purified solutions respectively by measuring Factor Xa and Factor IIa inhibition activity:
- Unfractionated Heparin (UFH)
- Enoxaparin Sodium (LMWH)
- Deltapain Sodium (LMWH)
- Nadroparin Calcium (LMWH)
- Tinzaparin Sodium (LMWH)
The quantitative determination of enzymatic levels by the measurement of their anti-Xa and IIa activity is a necessary tool for monitoring treatment efficacy.
Kits available are as per the Monograph indicated for USP/EP. The procedure is exactly as indicated in these monographs without any deviation, helping in easy setup. We have been instrumental in setting up these assays with leading Indian companies.
Krishgen uses highly specific antibody pairs for detection and coating, with proprietary stabilizers and blockers for optimal noise:signal ratio.
Components from the kit are also available separately for customers who wish to buy in bulk to reduce costs. We can also offer larger lots or custom packaging for our customers.
Compared to high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS), chromogenic assays are less expensive, less complex, and more readily accessible to laboratories with limited resources. Chromogenic assays offer a more straightforward way to measure heparin activity, and their results are not affected by issues such as column degradation or ion suppression.
Speciality Coagulation Enzyme Assays
The monograph for heparin prescribed in the United States Pharmacopeia (USP) can be found under the title “Heparin Sodium and Heparin Calcium Monographs”. The USP has revised these monographs and is continuing efforts to further revise them in the future, including the development of new potency assays and tests for impurities1.
For the monograph in the European Pharmacopoeia (EP), more specifically the European Pharmacopoeia 10.5 edition, it includes a monograph on “Heparin sodium” under the section “03/2018:2059 Heparin sodium”. It provides information about the properties, identification tests, purity, assay, and related substances of heparin sodium.
If you are unable to locate your desired ELISA kit on our website, or have a technical query, please drop us a message and our team will come back to you with availability. If we do not have it available, we will suggest a feasible custom development option.
Require a Custom Assay?
Krishgen can develop and manufacture to your specific requirements.
Whether you require a change in the assay range or sensitivity, want an assay validated for a specific matrix or even want an novel immunoassay developed, the Krishgen team can support you. Get a free technical consultation to learn about the feasibility and timeline of your new assay.