Comparison of methods for quantitative analysis of ranibizumab and bevacizumab in human plasma using various bioanalytical techniques, including microfluidic immunoassay, triple quadrupole, and high-resolution liquid chromatography-tandem mass spectrometry approaches.

With the ever-growing abundance of complex therapeutic proteins reaching clinical trials and post-marketing, it is vital to develop highly accurate and robust bioanalytical methods for their quantitative analysis in matrices, to support clinical trial data as well as therapeutic drug monitoring. In bioanalysis, proteins have traditionally been evaluated using ligand binding assays (LBAs). However, in recent years, bottom-up LC-MS/MS methods have begun to gain recognition as an alternative to LBAs in situations where either there is a desire to reduce lengthy development times, or where selectivity issues prevent the immunoassay from reaching the desired outcome.

Intact quantitative bioanalytical method development and fit-for-purpose validation of a monoclonal antibody and its related fab fragment in human vitreous and aqueous humor using LC-HRMS.

Ranibizumab is an FDA-approved drug used to treat wet age-related macular degeneration (AMD), diabetic retinopathy, macular edema, and myopic choroidal neovascularization. Bevacizumab is another drug often used off-label to treat wet AMD. In order to reduce unwanted angiogenesis, ranibizumab and bevacizumab target circulating VEGF-A in the eye.

Optimization and method validation for the quantitative analysis of a monoclonal antibody and its related fab fragment in human plasma after intravitreal administration, using LC-MS/MS.

As biologic based drugs become an increasingly important sector of the pharmaceutical industry, accurate and precision techniques for bioanalysis are required to support clinical trials and beyond. Ranibizumab, a fab therapeutic, is an FDA approved drug to treat wet age-related macular degeneration (AMD), as well as other eye related diseases. Ranibizumab's mAb counterpart, bevacizumab, is often also used off-label to treat wet AMD.