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A Comprehensive Immunocapture-LC-MS/MS Bioanalytical Approach in Support of a Biotherapeutic Ocular PK Study
Lin-Zhi Chen1, David Roos1, Elsy Philip1
1Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877, USA.
Pharmaceuticals (Basel, Switzerland)
|February 24, 2024
Summary
This study measured BI-X drug and albumin levels in monkey eyes after intravitreal injection. Bioanalytical methods were developed to support pharmacokinetic analysis of this therapeutic protein for ocular disease.
Area of Science:
- Ophthalmology
- Pharmacokinetics
- Bioanalysis
Background:
- BI-X is a therapeutic protein for ocular diseases administered via intravitreal injection.
- BI-X binds to targets and albumin in the eye's vitreous humor.
- Understanding BI-X pharmacokinetics is crucial for its development.
Purpose of the Study:
- To conduct a monkey ocular pharmacokinetic study of BI-X.
- To measure BI-X and albumin concentrations in ocular and systemic matrices.
- To validate bioanalytical methods for quantifying BI-X and albumin.
Main Methods:
- Developed and qualified five immunocapture-LC-MS/MS assays for BI-X.
- Utilized ELISA for albumin quantification.
- Analyzed drug and albumin levels in plasma, vitreous humor, aqueous humor, and retina tissue from monkeys.
Main Results:
- Established a comprehensive bioanalytical approach for ocular drug development.
- Successfully quantified BI-X and albumin levels across multiple matrices.
- Provided pharmacokinetic data supporting BI-X's ocular administration.
Conclusions:
- The developed bioanalytical methods are suitable for supporting ocular pharmacokinetic studies.
- This study provides essential pharmacokinetic data for the therapeutic protein BI-X.
- The findings support the further development of BI-X for treating human ocular diseases.
