Process development and characterization for integrated continuous bioprocesses—Highlights from <scp>N‐mAb</scp>-Reference-Cited by-同舟云学术

Process development and characterization for integrated continuous bioprocesses—Highlights from N‐mAb

Published:2024-01-30 Issue:4 Volume:40 Page:
ISSN:8756-7938
Container-title:Biotechnology Progress
language:en
Short-container-title:Biotechnology Progress

Author:

Brower Kevin¹^ORCID,Wiltberger Kelly²^ORCID,Berdugo Claudia³,Bosley Allen⁴,Goodrich Elizabeth⁵,Pferdeort Valerie⁶,Schaefer Gene⁷^ORCID

Affiliation:

1. Sanofi, Purification Development—Mammalian Platform Framingham Massachusetts USA

2. Biogen, Biologics Development, Biogen Research Triangle Park North Carolina USA

3. Catalent, Product Development Bloomington Indiana USA

4. AstraZeneca, Purification Process Sciences Gaithersburg Maryland USA

5. MilliporeSigma, Process Solutions R&D Bedford Massachusetts USA

6. Biogen, Cell Culture Development Research Triangle Park North Carolina USA

7. National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) Newark Delaware USA

Abstract

AbstractThe N‐mAb case study was produced by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to support teaching and learning for both industry and to accelerate adoption of advanced manufacturing process technologies such as integrated continuous bioprocesses (ICB) for mAbs. Similar to the A‐mAb case study, N‐mAb presents the evolution of an integrated control strategy, from early clinical through process validation and commercial manufacturing with a focus on elements that are unique to integrated continuous bioprocesses. This publication presents a summary of the process design and characterization chapters to allow a greater focus on the unique elements relevant to that phase of development.

Funder

National Institute for Innovation in Manufacturing Biopharmaceuticals

Publisher

Wiley

Link

https://aiche.onlinelibrary.wiley.com/doi/pdf/10.1002/btpr.3425

Reference31 articles.

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