کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
36861 | 45275 | 2016 | 13 صفحه PDF | دانلود رایگان |
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.
TrendsHere, I illustrate how to implement QbD and showcase the business drivers for this developmental system.A case study is presented to illustrate the step-by-step development of a purification process for the production of a biosimilar product.Advantages that QbD-based process development offers over traditional approaches, such as better yield and product quality, are highlighted and discussed
Journal: - Volume 34, Issue 5, May 2016, Pages 358–370