The increasing influx of biotherapeutics opens the door to designing new bioanalytical and validation strategies.
By Adrienne Clements-Egan, Ph.D., Janssen Research and Development, LLC (Johnson & Johnson); Boris Gorovits, Ph.D., Pfizer Inc.; and Heather Myler, Ph.D., PPD Laboratories
In the last five years, approved biotherapeutics in the United States and European Union have nearly doubled from preceding five-year periods.1 Approximately 50% of all novel approved drug products in the last five years were biotherapeutics in the U.S.1 Between January 2014 and July 2018, 68 monoclonal antibody (mAb)-derived therapeutics comprised the largest approval category, while the remaining approved products included 23 hormones, 16 clotting factors, 9 enzymes, 7 vaccines, 5 nucleic acids, 4 engineered cell therapies, and 1 RNAi for the U.S. and/or E.U.1 As the diversity and complexity of biotherapeutic modalities increase, our bioanalytical tool box must expand to experimentally determine their in vivo distribution, concentrations, and immunogenicity. Herein, we provide an overview and assessment of recently approved biotherapeutic modalities and summarize bioanalytical strategies and methods that can support the development of these increasingly complex biotherapeutics. Bioanalytical strategies, as described in publications, product labels, or published regulatory reviews,2 are presented for a variety of recently approved products of biotherapeutic, gene, and cell therapy classes.