Establishing a control system using QbD principles-Reference-Cited by-同舟云学术

Establishing a control system using QbD principles

Published:2016-09 Issue:5 Volume:44 Page:319-331
ISSN:1045-1056
Container-title:Biologicals
language:en
Short-container-title:Biologicals

Author:

Kepert J. Felix,Cromwell Mary,Engler Niklas,Finkler Christof,Gellermann Gerald,Gennaro Lynn,Harris Reed,Iverson Raquel,Kelley Brian,Krummen Lynne,McKnight Nathan,Motchnik Paul,Schnaible Volker,Taticek Ron

Publisher

Elsevier BV

Subject

Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology

Reference23 articles.

1. Understanding pharmaceutical quality by design;Yu;AAPS J,2014

2. Implementing quality by design for biotech products: are regulators on track?;Luciani;MAbs,2015

3. QbD Implementation and Post Approval Lifecycle Management (PALM);Ohage;Biologicals,2016

4. Process Characterization and Design Space Definition;Hakemeyer;Biologicals,2016

5. Determination of critical quality attributes for monoclonal antibodies using quality by design principles;Alt;Biologicals,2016

Cited by 37 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Aspects and Implementation of Pharmaceutical Quality by Design;Pharmaceutics;2024-06-19

2. Antibody-Drug Conjugate Overview: a State-of-the-art Manufacturing Process and Control Strategy;Pharmaceutical Research;2024-02-17

3. Six-Sigma Model in Pharma Industry: Part – II;Modern Aspects of Pharmaceutical Quality Assurance;2024

4. Managing integrated continuous bioprocesses in real time: Deviations in product quality;Biotechnology Progress;2023-11-28

5. Product-safety considerations in allogeneic chimeric antigen-receptor T-cell process flows;Current Opinion in Biotechnology;2022-12