Antibody-Drug Conjugates Assay Project

The inspection items of Antibody-Drug Conjugates (ADCs) usually include a series of tests to evaluate the quality, stability, efficacy, and safety of ADCs. These inspection items may include:

 

1. Quality Control Tests

Evaluating the purity, impurity level, antibody-drug binding ratio, etc., of ADCs.

 

2. Bioactivity Tests

Determining the recognition ability and killing effect of ADCs on target cells.

 

3. Stability Tests

Evaluating the stability of ADCs under different conditions (such as temperature, humidity, light, etc.).

 

4. Safety Assessment

Including toxicity tests, immunogenicity tests, etc., to evaluate potential risks to the human body.

 

5. Pharmacokinetic and Pharmacodynamic Studies

Understanding the distribution, metabolism, excretion process, and pharmacological properties of ADCs in the body.