A Single-use Strategy to Enable Manufacturing of Affordable Biologics

The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure...

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Detalles Bibliográficos
Autores principales: Jacquemart, Renaud, Vandersluis, Melissa, Zhao, Mochao, Sukhija, Karan, Sidhu, Navneet, Stout, Jim
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Research Network of Computational and Structural Biotechnology 2016
Materias:
Short Survey
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4990569/
https://www.ncbi.nlm.nih.gov/pubmed/27570613
http://dx.doi.org/10.1016/j.csbj.2016.06.007
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author Jacquemart, Renaud
Vandersluis, Melissa
Zhao, Mochao
Sukhija, Karan
Sidhu, Navneet
Stout, Jim
author_facet Jacquemart, Renaud
Vandersluis, Melissa
Zhao, Mochao
Sukhija, Karan
Sidhu, Navneet
Stout, Jim
author_sort Jacquemart, Renaud
collection PubMed
description The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure on manufacturers to produce at lower cost. Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly due to concerns related to cost and scale-up. This review summarizes how a single-use holistic process and facility strategy can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics. Technologies enabling high productivity, right-sized, small footprint, continuous, and automated upstream and downstream operations are evaluated in order to propose a concept for the flexible facility of the future.
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spelling pubmed-49905692016-08-26 A Single-use Strategy to Enable Manufacturing of Affordable Biologics Jacquemart, Renaud Vandersluis, Melissa Zhao, Mochao Sukhija, Karan Sidhu, Navneet Stout, Jim Comput Struct Biotechnol J Short Survey The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure on manufacturers to produce at lower cost. Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly due to concerns related to cost and scale-up. This review summarizes how a single-use holistic process and facility strategy can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics. Technologies enabling high productivity, right-sized, small footprint, continuous, and automated upstream and downstream operations are evaluated in order to propose a concept for the flexible facility of the future. Research Network of Computational and Structural Biotechnology 2016-07-05 /pmc/articles/PMC4990569/ /pubmed/27570613 http://dx.doi.org/10.1016/j.csbj.2016.06.007 Text en © 2016 Natrix Separations http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Short Survey
Jacquemart, Renaud
Vandersluis, Melissa
Zhao, Mochao
Sukhija, Karan
Sidhu, Navneet
Stout, Jim
A Single-use Strategy to Enable Manufacturing of Affordable Biologics
title A Single-use Strategy to Enable Manufacturing of Affordable Biologics
title_full A Single-use Strategy to Enable Manufacturing of Affordable Biologics
title_fullStr A Single-use Strategy to Enable Manufacturing of Affordable Biologics
title_full_unstemmed A Single-use Strategy to Enable Manufacturing of Affordable Biologics
title_short A Single-use Strategy to Enable Manufacturing of Affordable Biologics
title_sort single-use strategy to enable manufacturing of affordable biologics
topic Short Survey
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4990569/
https://www.ncbi.nlm.nih.gov/pubmed/27570613
http://dx.doi.org/10.1016/j.csbj.2016.06.007
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