title: Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic.
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.
authors.affiliation: Department of Chemical Engineering, Indian Institute of Technology, New Delhi, 110016, India. Electronic address: asrathore@biotechcmz.com.
authors.forename: Anurag S
authors.initials: AS
authors.lastname: Rathore
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000302:isolation & purification*; D002845:Chromatography; D012107:Research Design / Q000592:standards*; D013678:Technology, Pharmaceutical / Q000379:methods / Q000592:standards
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: PAT; QbD; critical quality attributes; design space; process analytical technology; quality by design; risk assessment