by Kathleen M. Hanley, PhD, and Jeanne Novak, PhD
Volume 6, Issue 3 (Fall 2007)
The analytical characterization of recombinant protein therapeutic drug products has broadened to include the use of more sophisticated technologies. The expansion of technical abilities has translated into increasing the depth and breadth of our knowledge and understanding of the drug product intended for commercialization. With the availability of more precise methods, the regulatory expectations for understanding the characteristics of a protein therapeutic drug product are increasing. A thorough understanding of a therapeutic protein’s biochemical and biophysical characteristics is necessary to support investigational new drug (IND) applications and other drug regulatory filings…
Citation:
Hanley KM, Novak J. Product Characterization of Recombinant Proteins and Monoclonal Antibodies. BioProcess J, 2007; 6(3): 18-29. http://dx.doi.org/10.12665/J63.Hanley