Evolving CMC Analytical Techniques for Biopharmaceuticals: Article in ADC Review
Learn from Glenn Petrie, Ph.D., EAG’s Senior Scientific Advisor in a recent article published in ADC Review, the Journal of Antibody Drug Conjugates, October 21, 2016.
During the (early) preclinical drug development process as well as manufacturing of biopharmaceutical (protein) products, analysis and characterization are crucial in gaining a better understanding of the physical and chemical properties of various materials. These properties can have an impact on the manufacturability as well as the performance, potential for metabolism, stability and appearance of a specific medicinal product. Hence, properly characterizing these products is essential for a drug candidate to move from drug development to regulatory approval and, finally, the clinic.
In recent years, complex biopharmaceutical drugs and biologics have evolved into mainstream therapeutics. The manufacturing of these compounds, including monoclonal antibodies, bispecifics, antibody-drug conjugates(ADCs), recombinant and other therapeutic proteins, require extensive analytical and comprehensive characterization using a variety of techniques, including non-compendial, and sometimes an intricate quality control methodology, to confirm manufacturing consistency and product quality.
Because biopharmaceuticals and biologics exhibit highly diverse structures and broad biological activities, a study of these agents is a relatively complex process requiring sophisticated analytical techniques. Furthermore, in addition to these complexities, regulatory expectations to better understand product impurities and degradants in biopharmaceutical products continue to increase.
As a result, many drug developers may find that their current global chemistry, manufacturing, and control (CMC) systems are quickly becoming obsolete. Consequently, new, highly sensitive and specific technologies are becoming the new normal.