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Updated: Mar 25, 2026

Author Spotlight: Process Development for the Spray-Drying of Probiotic Bacteria and Evaluation of the Product Quality
Published on: April 7, 2023
Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic
1Department of Chemical Engineering, Indian Institute of Technology, New Delhi, 110016, India.
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.
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