Role of raw materials in biopharmaceutical manufacturing: risk analysis and fingerprinting. (October 2018)

• Record Type: Journal Article
• Authors: Rathore, Anurag S; Kumar, Deepak; Kateja, Nikhil
• Is Part Of: Current opinion in biotechnology. Volume 53(2018)
• Page Start: 99
• Page End: 105
• Publication Date: 2018-10
• Subjects: Biotechnology -- Periodicals; 660.6
• DOI: 10.1016/j.copbio.2017.12.022
• Languages: English
• ISSNs: 0958-1669

Abstract

Abstract : Accurate fingerprinting of critical raw materials that have significant impact on process performance and product quality is a necessary precursor for implementation of QbD in process and product development. This article presents a review of major developments in this space in the last 10 years, with a special emphasis on those in last 5 years. A step by step approach for managing raw materials in the QbD paradigm has been proposed. We think that it is necessary for the biotech industry to better manage variability originating from raw materials if holistic implementation of QbD is to be achieved.