Analytical Method Development for Antibody-Based Drugs in Biological Samples using LC-MS/MS
We offer highly reliable analytical services for antibody-based drugs that do not require antibody reagents, thereby accelerating your research and development.
Features
1.Rapid and Cost-Effective Analysis
Our analyses are both rapid and cost-effective because there is no need to develop and produce antibody reagents.
Comparison of Conventional ELISA and LC-MS/MS Methods
| Items | Conventional Method (ELISA) | LC-MS/MS Method |
|---|---|---|
| Antigens, antibody reagents | Required (time-consuming, costly) | Not required (rapid and cost-effective) |
| Linearity range | Narrow (1–2 orders of magnitude) | Wide (3–4 orders of magnitude) |
| Effects of ADA and antigens | Can be affected by ADA and antigens | Not affected by ADA and antigens |
| Sensitivity | High | Lower than ligand‑binding assays (LBA) (see note) |
| Measurement period | Short | Long |
- *Note: The sensitivity of LC-MS/MS is sufficiently high for non-clinical safety studies (using large animals) as well as repeated-dose clinical studies.
We have confirmed that the results obtained using the LC-MS/MS method correlate well with those obtained using the conventional ELISA method. In response to your requests, we can optimize and propose the most appropriate analytical methods.
2.Optimization of Analytical Methods in the Following Cases:
- Complex Physical Properties:
By leveraging our expertise in preventing adsorption and ensuring stability, we optimize analytical methods according to the physical properties of your drugs. - Alternative Quantification Using Peptides:
We propose a highly reproducible enzymatic digestion method for peptide-based quantification. - Large Amount of Contaminants:
We select the most efficient workflow by leveraging our know-how in sample pretreatment and LC separation techniques. - Internal Standard Selection:
We select appropriate internal standards for LC based on our extensive experience. - Use of Humanized Antibody CDR-Derived Peptides:
The same peptides can be used continuously from nonclinical to clinical studies.
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