An Approach to Quality and Security of Supply for Single-Use Bioreactors View Full Text


Ontology type: schema:Chapter     


Chapter Info

DATE

2013

AUTHORS

Magali Barbaroux , Susanne Gerighausen , Heiko Hackel

ABSTRACT

Single-use systems (also referred to as disposables) have become a huge part of the bioprocessing industry, which raised concern in the industry regarding quality and security of supply. Processes must be in place to assure the supply and control of outsourced activities and quality of purchased materials along the product life cycle. Quality and security of supply for single-use bioreactors (SUBs) are based on a multidisciplinary approach. Developing a state-of-the-art SUB-system based on quality by design (QbD) principles requires broad expertise and know-how including the cell culture application, polymer chemistry, regulatory requirements, and a deep understanding of the biopharmaceutical industry. Using standardized products reduces the complexity and strengthens the robustness of the supply chain. Well-established supplier relations including risk mitigation strategies are the basis for achieving long-term security of supply. Well-developed quality systems including change control approaches aligned with the requirements of the biopharmaceutical industry are a key factor in supporting long-term product availability. This chapter outlines the approach to security of supply for key materials used in single-use production processes for biopharmaceuticals from a supplier perspective. More... »

PAGES

239-72

Book

TITLE

Disposable Bioreactors II

ISBN

978-3-642-45157-7
978-3-642-45158-4

Author Affiliations

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/10_2013_198

DOI

http://dx.doi.org/10.1007/10_2013_198

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1032605472

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/23793913


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