title: Characterizing biological products and assessing comparability following manufacturing changes.
abstract: 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.
authors.affiliation: Xencor Inc., 111 West Lemon Avenue, Monrovia, Calfornia 91016, USA. art@xencor.com
authors.forename: Arthur J
authors.initials: AJ
authors.lastname: Chirino
authors.forename: Anthony
authors.initials: A
authors.lastname: Mire-Sluis
mesh_terms: D001688:Biological Products / Q000032:analysis* / Q000737:chemistry* / Q000145:classification / Q000592:standards; D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000379:methods; D004345:Drug Industry / Q000379:methods* / Q000592:standards; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D013810:Therapeutic Equivalency; D014481:United States
chemical_list: D001688:Biological Products