Roadmap for implementation of quality by design (QbD) for biotechnology products

Quality by design (QbD) has been receiving a lot of attention in the pharmaceutical community of late. Successful QbD implementation requires a thorough understanding of the relationship between the critical quality attributes (CQAs) and the clinical properties of the product, the relationship betwe...

Full description

Saved in:
Bibliographic Details
Published in:Trends in biotechnology (Regular ed.) 2009-09, Vol.27 (9), p.546-553
Main Author: Rathore, Anurag S
Format: Article
Language:English
Subjects:
Biological and medical sciences
Biotechnology
Biotechnology - methods
Biotechnology industry
Drug Industry - methods
Fundamental and applied biological sciences. Psychology
Health. Pharmaceutical industry
Industrial applications and implications. Economical aspects
Internal Medicine
Manufacturing
Miscellaneous
Pharmaceutical industry
Pharmaceutical Preparations - standards
Product development
Quality Control
Raw materials
Regulatory agencies
Technology, Pharmaceutical
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Quality by design (QbD) has been receiving a lot of attention in the pharmaceutical community of late. Successful QbD implementation requires a thorough understanding of the relationship between the critical quality attributes (CQAs) and the clinical properties of the product, the relationship between the process and CQAs and the variability in raw materials. This article presents a roadmap for successful QbD implementation for therapeutic biotechnology products. The approach presented here is aligned with existing regulatory guidance documents. Key developments are reviewed and case studies are used to illustrate these concepts. It is concluded that although several QbD concepts are being practiced by the biotechnology industry, successful dialogue and partnership between the industry and its regulators will be the key to successful QbD implementation.
ISSN:0167-7799
1879-3096
DOI:10.1016/j.tibtech.2009.06.006