Nature Biotechnology22, 1383 - 1391 (2004)
Published online: 4 November 2004; | doi:10.1038/nbt1030
Characterizing biological products and assessing comparability following manufacturing changes
Arthur J Chirino1
& Anthony Mire-Sluis2
1
Xencor Inc., 111 West Lemon Avenue, Monrovia, Calfornia 91016, USA.
2
Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, 1451 Rockville Pike, Maryland 20852, USA.
Correspondence should be addressed to Arthur J Chirino art@xencor.com
Changes in production methods of a biological product may necessitate an assessment of comparability to ensure that these manufacturing changes have not affected the safety, identity, purity, or efficacy of the product. Depending on the nature of the protein or the change, this assessment consists of a hierarchy of sequential tests in analytical testing, preclinical animal studies and clinical studies. Differences in analytical test results between pre- and post-change products may require functional testing to establish the biological or clinical significance of the observed difference. An underlying principle of comparability is that under certain conditions, protein products may be considered comparable on the basis of analytical testing results alone. However, the ability to compare biological materials is solely dependent on the tests used, since no single analytical method is able to compare every aspect of protein structure or function. The advantages and disadvantages of any given method depends on the protein property being characterized.
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