Comparability Considerations and Challenges for Expedited Development Programs for Biological Products.

ABSTRACT: Expedited development programs for biological products to be used in the treatment of serious conditions bring about challenges because of the compressed clinical development timeframes. As expedited development does not lessen the quality expectations, one challenge is providing adequate chemistry, manufacturing, and control (CMC) information required to support approval of a biological product. In particular, the analytical comparability and, in some cases, pharmacokinetic comparability studies needed to bridge the clinical material to the commercial material could delay submission of applications for life-saving medicines. While there is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Topic Q5E guidance on assessing comparabi

SUBMITTER: Schrieber SJ 

PROVIDER: S-EPMC7691403 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature