Literature DB >> 26879188

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

Anurag S Rathore1.   

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.
Copyright © 2016 Elsevier Ltd. All rights reserved.

Entities:  

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

Mesh：

Substances：

Year:  2016        PMID： 26879188     DOI： 10.1016/j.tibtech.2016.01.003

Source DB:  PubMed          Journal:  Trends Biotechnol        ISSN： 0167-7799            Impact factor:   19.536


  7 in total

1.  Determination of Critical Quality Attributes for a Biotherapeutic in the QbD Paradigm: GCSF as a Case Study.

Authors:  Sumit K Singh; Deepak Kumar; Anurag S Rathore
Journal:  AAPS J       Date:  2017-09-05       Impact factor: 4.009

2.  Real-time monitoring and model-based prediction of purity and quantity during a chromatographic capture of fibroblast growth factor 2.

Authors:  Dominik Georg Sauer; Michael Melcher; Magdalena Mosor; Nicole Walch; Matthias Berkemeyer; Theresa Scharl-Hirsch; Friedrich Leisch; Alois Jungbauer; Astrid Dürauer
Journal:  Biotechnol Bioeng       Date:  2019-04-17       Impact factor: 4.530

3.  Automated multi-attribute method sample preparation using high-throughput buffer exchange tips.

Authors:  Yuko Ogata; Pamela M Quizon; Nancy S Nightlinger; Pongkwan Sitasuwan; Casey Snodgrass; L Andrew Lee; Jeffrey D Meyer; Richard S Rogers
Journal:  Rapid Commun Mass Spectrom       Date:  2022-01-30       Impact factor: 2.586

Review 4.  Development of L-Asparaginase Biobetters: Current Research Status and Review of the Desirable Quality Profiles.

Authors:  Larissa Pereira Brumano; Francisco Vitor Santos da Silva; Tales Alexandre Costa-Silva; Alexsandra Conceição Apolinário; João Henrique Picado Madalena Santos; Eduardo Krebs Kleingesinds; Gisele Monteiro; Carlota de Oliveira Rangel-Yagui; Brahim Benyahia; Adalberto Pessoa Junior
Journal:  Front Bioeng Biotechnol       Date:  2019-01-10

5.  Quality by Design Micro-Engineering Optimisation of NSAID-Loaded Electrospun Fibrous Patches.

Authors:  Kazem Nazari; Prina Mehta; Muhammad Sohail Arshad; Shahabuddin Ahmed; Eleftherios G Andriotis; Neenu Singh; Omar Qutachi; Ming-Wei Chang; Dimitrios G Fatouros; Zeeshan Ahmad
Journal:  Pharmaceutics       Date:  2019-12-18       Impact factor: 6.321

6.  Quantitative analysis of operators' flow line in the cell culture for controlled manual operation.

Authors:  Kei Kanie; Hiroto Sasaki; Yurika Ikeda; Masaki Tamada; Fumio Togawa; Ryuji Kato
Journal:  Regen Ther       Date:  2019-05-14       Impact factor: 3.419

Review 7.  Evolution of Escherichia coli Expression System in Producing Antibody Recombinant Fragments.

Authors:  Annamaria Sandomenico; Jwala P Sivaccumar; Menotti Ruvo
Journal:  Int J Mol Sci       Date:  2020-08-31       Impact factor: 5.923
  7 in total

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