Flexible Biomanufacturing Processes that Address the Needs of the Future View Full Text


Ontology type: schema:Chapter     


Chapter Info

DATE

2013

AUTHORS

Bernhard Diel , Christian Manzke , Thorsten Peuker

ABSTRACT

: As the age of the blockbuster drug recedes, the business model for the biopharmaceutical industry is evolving at an ever-increasing pace. The personalization of medicine, the emergence of biosimilars and biobetters, and the need to provide vaccines globally are just some of the factors forcing biomanufacturers to rethink how future manufacturing capability is implemented. One thing is clear: the traditional manufacturing strategy of constructing large-scale, purpose-built, capital-intensive facilities will no longer meet the industry's emerging production and economic requirements. Therefore, the authors of this chapter describe the new approach for designing and implementing flexible production processes for monoclonal antibodies and focus on the points to consider as well as the lessons learned from past experience in engineering such systems. A conceptual integrated design is presented that can be used as a blueprint for next-generation biomanufacturing facilities. In addition, this chapter discusses the benefits of the new approach with respect to flexibility, cost, and schedule. The concept presented here can be applied to other biopharmaceutical manufacturing processes and facilities, including-but not limited to-vaccine manufacturing, multiproduct and/or multiprocess capability, clinical manufacturing, and so on. More... »

PAGES

207-37

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/10_2013_220

DOI

http://dx.doi.org/10.1007/10_2013_220

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1000101850

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23949696


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