Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic

Anurag S Rathore

doi:10.1016/j.tibtech.2016.01.003

Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic

Trends Biotechnol. 2016 May;34(5):358-370. doi: 10.1016/j.tibtech.2016.01.003. Epub 2016 Feb 13.

Author

Anurag S Rathore¹

Affiliation

¹ Department of Chemical Engineering, Indian Institute of Technology, New Delhi, 110016, India. Electronic address: asrathore@biotechcmz.com.

PMID: 26879188
DOI: 10.1016/j.tibtech.2016.01.003

Abstract

Quality by Design (QbD) is currently receiving increased attention from the pharmaceutical community. As a result, most major biotech manufacturers are in varying stages of implementing QbD. Here, I present a case study that illustrates the step-by-step development using QbD of a purification process for the production of a biosimilar product: granulocyte colony-stimulating factor (GCSF). I also highlight and discuss the advantages that QbD-based process development offers over traditional approaches. The case study is intended to help those who wish to implement QbD towards the development and commercialization of biotech products.

Keywords: PAT; QbD; critical quality attributes; design space; process analytical technology; quality by design; risk assessment.

Publication types

Review

MeSH terms

Biosimilar Pharmaceuticals / isolation & purification*
Chromatography
Research Design / standards*
Technology, Pharmaceutical* / methods
Technology, Pharmaceutical* / standards

Substances

Biosimilar Pharmaceuticals