Monoclonal antibodies (mABs) are immunoglobulin molecules that bind to the same epitope and have a variety of applications in medicine and healthcare (e.g. as drugs). Although therapeutic mABs are extremely favorable due to their specificity, they are heterogeneous due to their manufacturing process and hence provide a challenge for characterization.
In today’s small blog article, we will learn about bioanalytical method validation and its recent advancements. Bioanalytical method validation refers to validation of analytical methods that deal with analysis of an analyte in biological matrices (like urine, saliva, blood etc.). Validation of such methods for the quantitative determination of analytes (e.g. drugs under development or their metabolites) and biomarkers in a given bio-matrix are critical for the successful conduct of nonclinical and clinical pharmacology studies.
In today’s blog article we will learn about the System Suitability Testing of analytical methods in the pharmaceutical field, its importance in quality control (QC) of drugs and how it differs from the Analytical Instrument Qualification.
Methods that are used in a pharmaceutical quality control (QC) lab for characterization, release, and stability testing of drugs (biologicals or small molecules) are called analytical methods in the official guidelines. Analytical methods are not synonymous to bioanalytical methods as referred by many. In today’s blog article we will learn about the distinct differences between the two and their respective validation procedures.