Reference Materials for Complex Biological Products

by Keith L. Carson
Volume 2, Issue 1 (January/February 2003)

As advanced analytical techniques become more widely used for product testing, and as more biological products become better characterized, the expectations increase that all biological products will become well characterized. Certainly, the trend is for all regulated products to become better characterized, and for a growing set of analytical methods to attain common usage. As more data is presented in regulatory submissions and reviews, similar data is expected, or desired, in most future product submissions. Furthermore, the techniques being used are opening additional avenues of product testing that regulators may want to see, or that the larger companies could establish as commonly accepted practice...

Carson KL. Reference Materials for Complex Biological Products. BioProcess J, 2003; 2(1): 17-21.