Continuous integrated manufacturing for biopharmaceuticals: A new paradigm or an empty promise?

Continuous integrated bioprocessing has elicited considerable interest from the biopharma industry for the many purported benefits it promises. Today many major biopharma manufacturers around the world are engaged in the development of continuous process platforms for their products. In spite of gre...

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Bibliographic Details
Published in:Biotechnology and bioengineering 2023-02, Vol.120 (2), p.333-351
Main Authors: Rathore, Anurag S., Thakur, Garima, Kateja, Nikhil
Format: Article
Language:English
Subjects:
Biological products
Biological Products - chemistry
Biopharmaceuticals
Bioprocessing
Biotechnology
continuous integrated bioprocessing
Drug Industry
Manufacturers
Manufacturing
manufacturing platforms
Pharmacology
process integration
Product development
Production costs
Technology, Pharmaceutical
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Summary:Continuous integrated bioprocessing has elicited considerable interest from the biopharma industry for the many purported benefits it promises. Today many major biopharma manufacturers around the world are engaged in the development of continuous process platforms for their products. In spite of great potential, the path toward continuous integrated bioprocessing remains unclear for the biologics industry due to legacy infrastructure, process integration challenges, vague regulatory guidelines, and a diverging focus toward novel therapies. In this article, we present a review and perspective on this topic. We explore the status of the implementation of continuous integrated bioprocessing among biopharmaceutical manufacturers. We also present some of the key hurdles that manufacturers are likely to face during this implementation. Finally, we hypothesize that the real impact of continuous manufacturing is likely to come when the cost of manufacturing is a substantial portion of the cost of product development, such as in the case of biosimilar manufacturing and emerging economies.
ISSN:0006-3592
1097-0290
DOI:10.1002/bit.28235