Nov 5, 2013 – MSDG Meeting

Abstract for Talk I:

Clinical Pharmacology plays an important role in drug development, including the evaluation of the drug’s pharmacokinetics (PK), pharmacodynamics (PD), drug interaction potential, exposure-response relationship, and safety considerations when being used in specific populations.

Clinical Pharmacology data is pivotal in delivering the right drug, in the right dose, at the right time, to each particular patient and it has significantly influenced the risk/benefit assessment and labeling recommendations. Consequently, the reliability of that data is of considerable importance and bioanalysis is the solid footing in drug development ensuring the reliability. Bioanalytical data and documentation from method validation or clinical trials are critical elements supporting regulatory submissions such as new drug applications (NDAs) or biologics license application (BLAs).

Case examples will be presented to highlight the utility and importance of bioanalysis in drug development to ensure that drug products are safe, effective, and given at the right dose.

Abstract for Talk II:

The last few years have seen an abundance of biologics (from peptides to monoclonal antibodies) entering the pharmaceutical pipeline, and it is believed that in the next few years, the pharmaceutical pipeline will contain nearly 50% biologics. In addition, with the patent expiration of several biologics recently, and many more scheduled to come off patent in the future, there is likely to be a steady rise in the number of biosimilars on the market. However, developing robust and reproducible LC/MS or sensitive LC/MS/MS methodologies to characterize and quantify these diverse compounds is significantly more complicated from those developed for small molecules. An evolving regulatory environment, particularly in the late stage studies for both innovator biologics and follow-on biosimilars, adds to this complexity.

As a result there is an increased demand for simple workflows using LC/MS or LC/MS/MS that offer users the ability to develop sensitive, robust, and reproducible methods that address regulatory demands as required. This talk will highlight the workflows that were used for characterization of the key features of Biologics using an LC/MS platform with time-of-flight technology, inclusive but not limited to: advanced peptide mapping, whole protein analyses, Antibody Drug Conjugate characterization, sequence variant analysis, and identification and quantitation of Host Cell Proteins.