Attempting to create an exact duplicate of the comparator product would be a fool's errand. Variations such as primary amino acid sequence, glycosylation chemical modifications and protein folding issues are common. Your challenge is to determine whether those differences have clinical significance—and when they do, to make well informed mid-course adjustments to keep development moving forward.
Choosing the Right Analytical Partner May Be the Most Economically Important Decision You Make
Recent FDA guidance calls for a "complete and thorough" CMC section that begins with extensive comparative characterization of the biosimilar and reference products. This information is used to substantiate chemical, physical and bioactive similarity, which ultimately will influence the scope and number of animal and clinical studies that will be required to demonstrate interchangeability. In other words, a deficit in analytical characterization expertise can equate to a great deal of...
Click here for the rest at abclabs.com
No comments:
Post a Comment