PT  - JOURNAL ARTICLE
AU  - Kavita Ramalingam Iyer
AU  - Isabelle Lequeux
TI  - Proposed approach to scientific risk-based comparability study Design for biologics
AID  - 10.5731/pdajpst.2019.010439
DP  - 2020 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2019.010439
4099  - http://journal.pda.org/content/early/2020/04/15/pdajpst.2019.010439.short
4100  - http://journal.pda.org/content/early/2020/04/15/pdajpst.2019.010439.full
AB  - Chemistry, Manufacturing and Control Post-Approval Changes are an intrinsic part of the lifecycle of pharmaceutical products. In this paper, the authors examine the potential impact of such changes on product quality, safety and efficacy of biologics. Comparability studies and more specifically analytical comparability are introduced as one of the tools that can support both biomanufacturers and health agencies in ensuring that patient safety, product safety and efficacy is maintained through the proposed changes. Together with a scientific risk-based review approach based on product and process knowledge and the definition of acceptance criteria that will ensure that the product is ′essentially similar′, what constitutes a holistic comparability study is detailed. ICH Guidelines principles and definitions are used throughout the paper to aid the reader with other appropriate references. Finally, three case studies are presented: change to the manufacturing facility of the drug substance, change to the manufacturing process of a drug substance intermediate and manufacturing facility, and justification of not including drug product in analytical compatibility.