Anti-MTX payload antibody in PK study in ADC drug development

As the tracer agent in PK studies, anti-MTX antibodies help to calculate the concentration of methotrexate in the biological samples. Methotrexate belongs to the class of antimetabolite drugs and functions as an immunosuppressant tool in the treatment of various diseases: cancer, rheumatoid arthritis and psoriasis. It does this by inhibiting the conversion of folic acid which is used to make proteins used in DNA replication and cell division.

**Product list of GeneMedi's anti-MTX antibody**
Cat No.	Product Description	Fc	Products Information
GTU-Bios-MTX-Ab	Anti-MTX-monoclonal-antibody (mAb)	hFc/mFc	Details

All Payloads of ADCs

Application

Competitive immunoassay validation (CompetitiveELISA) and other Immunoassay,
PK & PD assay for MMAE payload of Antibody-drug Conjugate (ADC)

Highlight:

Purity: ≥95% (SDS-PAGE)
High affinityand specificity validated
High sensitivity verified by ADCs binding assay

Application
Technical Resource

Why Use Anti-MTX Antibody in ADC drug development?

Specificity: Anti-MTX antibodies are intended to bind specifically to MTX only but also to different substances or metabolite products in the body. Such specificity is crucial in apportioning accurate concentration of methotrexate as it is a factor that defines the pharmacokinetics of the drug being developed.
Sensitivity: These antibodies make it possible to assess the level of methotrexate in the blood, this is extremely important if during the therapy it is necessary to apply very small amounts of such medicines as methotrexate during a long time. This is crucial because the level of the drug in the body can be measured and one can make sure that he or she does not get to the toxic level which is referred to as the therapeutic window.
Therapeutic Monitoring and Safety: The medication has significant side effects implicated and risk-reward ratio of methotrexate is not as sweeping as the rest of the drugs mentioned here and that is why the dosage should not be off. We mentioned in an earlier section that anti MTX antibodies helps in determining the drug concentration in body and ensures that they are within therapeutic level. This is even more relevant with patients who might have dissimilar MK absorption patterns based on their rate of metabolism or their renal function problems.

How to use Anti-MTX Antibody in ADC drug development?

Development of Immunoassays: Anti-MTX antibodies employed in preparing immunoassay, for instance, ELISA that which is used to measure methotrexate levels in plasma, serum, or any other body fluid. These assays are useful in determining the pharmacokinetics of methotrexate regime of the substance such as absorption, distribution, metabolism and elimination.
Sample Collection and Analysis: In a pharmacokinetic study, blood samples are collected serially in timed periods after the administration of methotrexate. These samples are then subjected to the immunoassays in which the anti-MTX antibodies are used to determine the level of methotrexate at the different time intervals.
Data Interpretation and Clinical Application: Such assays aid in definition of the pharmacokinetic characteristics of Methotrexate to help define therapeutic regimens. This information is then used to alter doses in patient to in order to achieve optimal Therapeutic Index while suppressing the Toxicity Index.

In PK studies, the presence of anti-MTX antibodies aids in making methotrexate treatment a more personalized approach that targets the disease while mitigating side effects in patients. The approach is most suitable in disease management that require a strict mode of treatment like cancer and autoimmune diseases.