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BibTeX
Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture
Biotechnology progress, 2017-07, Vol.33 (4), p.854-866
Pollock, James
Coffman, Jon
Ho, Sa V.
Farid, Suzanne S.
2017
Volltextzugriff (PDF)
Details
Autor(en) / Beteiligte
Pollock, James
Coffman, Jon
Ho, Sa V.
Farid, Suzanne S.
Titel
Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture
Ist Teil von
Biotechnology progress, 2017-07, Vol.33 (4), p.854-866
Ort / Verlag
United States: Wiley Subscription Services, Inc
Erscheinungsjahr
2017
Quelle
Wiley Online Library - AutoHoldings Journals
Beschreibungen/Notizen
This paper presents a systems approach to evaluating the potential of integrated continuous bioprocessing for monoclonal antibody (mAb) manufacture across a product's lifecycle from preclinical to commercial manufacture. The economic, operational, and environmental feasibility of alternative continuous manufacturing strategies were evaluated holistically using a prototype UCL decisional tool that integrated process economics, discrete‐event simulation, environmental impact analysis, operational risk analysis, and multiattribute decision‐making. The case study focused on comparing whole bioprocesses that used either batch, continuous or a hybrid combination of batch and continuous technologies for cell culture, capture chromatography, and polishing chromatography steps. The cost of goods per gram (COG/g), E‐factor, and operational risk scores of each strategy were established across a matrix of scenarios with differing combinations of clinical development phase and company portfolio size. The tool outputs predict that the optimal strategy for early phase production and small/medium‐sized companies is the integrated continuous strategy (alternating tangential flow filtration (ATF) perfusion, continuous capture, continuous polishing). However, the top ranking strategy changes for commercial production and companies with large portfolios to the hybrid strategy with fed‐batch culture, continuous capture and batch polishing from a COG/g perspective. The multiattribute decision‐making analysis highlighted that if the operational feasibility was considered more important than the economic benefits, the hybrid strategy would be preferred for all company scales. Further considerations outside the scope of this work include the process development costs required to adopt continuous processing. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 33:854–866, 2017
Sprache
Englisch
Identifikatoren
ISSN: 8756-7938
eISSN: 1520-6033
DOI: 10.1002/btpr.2492
Titel-ID: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5575510
Format
–
Schlagworte
Antibodies, Monoclonal - biosynthesis
,
Antibodies, Monoclonal - economics
,
antibody manufacture
,
Batch Cell Culture Techniques - economics
,
Bioprocessing
,
Biotechnology
,
Chromatography
,
Chromatography - economics
,
continuous chromatography
,
Decision analysis
,
Decision Making
,
Discrete event systems
,
Ecological risk assessment
,
Economic analysis
,
Economic impact
,
Environment
,
Environmental impact
,
Environmental impact assessment
,
Feasibility studies
,
fed‐batch
,
Impact analysis
,
Manufacturing Industry - economics
,
Monoclonal antibodies
,
perfusion culture
,
Polishing
,
process economics
,
Risk analysis
,
Special Section on Continous Bioprocessing
,
Strategy
,
Systems analysis
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