Principles for specification establishment of biological products
LI Min
CHANG Wei-hong
Abstract：Biologics are highly heterogeneous in compositions and complicated in structures,whose specifications should be product-specific based on full characterization of the products.The establishment of specifications is a comprehensive process of design,qualification and continued verification of the results of chemistry manufacture and controls (CMC) study,pre-clinical study,clinical study and post-marketing study which exists throughout the whole life cycle of the product.This article discussed the general considerations of how to standardize the specifications of biological products,taking the international technical guidelines and some real cases of new drug review into consideration,to provide reference for industry and reviewers.
Keywords：biological productcritical quality attributespecificationlife cycle of products
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1887-1893 )