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

Paper ID Volume ID Publish Year Pages File Format Full-Text
36861 45275 2016 13 PDF Available
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.

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

Keywords
quality by design; QbD; risk assessment; design space; critical quality attributes; process analytical technology; PAT
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Quality by Design (QbD)-Based Process Development for Purification of a Biotherapeutic
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Publisher
Database: Elsevier - ScienceDirect
Journal: - Volume 34, Issue 5, May 2016, Pages 358–370
Authors
,
Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us