Manufacturing

Shreefal S. Mehta

doi:10.1017/9781108186698.008

7 - Manufacturing

Published online by Cambridge University Press: 03 November 2022

Shreefal S. Mehta

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Shreefal S. Mehta: Affiliation:
The Paper Battery Company

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Summary

Preparing for scale-up in commercial manufacturing is far away from the thoughts of companies involved in product development, but this chapter shows when to start planning and how to plan a practical budget for this activity. For companies with their first product in commercial development, the build vs buy decision is never an easy one and the examples and key points for consideration simplify that process. The biggest challenge in scaling up is the gap in culture between R&D production for experimental testing in preclinical stages and the control and quality oriented culture in the manufacturing location. The case studies and content in the chapter specifically highlight how to achieve a successful technology transfer into commercial GMP manufacturing. The chapter content also gives practical guidelines on what it takes to put GMP and quality systems in place.

Keywords

compliance GMP GLP batch size validation control clean room technology transfer R&D manufacturing process validation quality design for manufacturing API excepients labeling buy or build outsourcing supply chain.

Type: Chapter
Information: Commercializing Successful Biomedical Technologies , pp. 309 - 362

DOI: https://doi.org/10.1017/9781108186698.008 [Opens in a new window]

Publisher: Cambridge University Press

Print publication year: 2022

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References

References and additional readings

Avis, KE, Wagner, CM, and Wu, VL. (2019). Biotechnology: Quality Assurance and Validation (Drug Manufacturing Technology Series). CRC Press. ISBN: 978-0367400255Google Scholar

Bhatia, S. (2012). Microfabrication in Tissue Engineering and Bioartificial Organs (Microsystems). Springer Press. ISBN: 978-1461373865Google Scholar

Business Week Online. (August 13, 2001). The corporation: biotech and the spoils of success. (author unknown).Google Scholar

Bunn, G. (2019). Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality Control, 7th ed. CRC Press. ISBN: 978-1498732062CrossRef Google Scholar

Davim, JP. (2012). The Design and Manufacture of Medical Devices. Woodhead Publishing. ISBN: 978-1907568725CrossRef Google Scholar

Gee, A. (editor). (2009). Cell Therapy: cGMP Facilities and Manufacturing. Springer Press. ISBN: 978-0387895833Google Scholar

Lefevre, G. (January 17, 2001). Hip replacement patients may face more surgery. CNN.Google Scholar

Levin, M. (editor). (2011). Pharmaceutical Process Scale-Up. CRC Press. ISBN: 978-1616310011.Google Scholar

McCormick, D. (2004, November). Small changes, big effects in biological manufacturing. Pharmaceutical Science and Technology News, 16 (accessed online August 2006).Google Scholar

National Standards Policy Advisory Committee. (December 1978). National Policy on Standards for the United States and a Recommended Implementation Plan. Washington, DC, p. 6.Google Scholar

Schellekens, H, and Jiskoot, W. (2006). Eprex-associated pure red cell aplasia and leachates. Nature Biotechnology, 24(6), 613–614.CrossRef Google Scholar PubMed

Shuler, ML, Kargi, F, and DeLisa, M. (2017). Bioprocess Engineering: Basic Concepts, 3rd ed. Pearson Press. ISBN: 978-0137062706Google Scholar

Signore, A, and Jacobs, T. (editors). (2016). Good Design Practices for GMP Pharmaceutical Facilities, 2nd ed. CRC Press. ISBN: 978-1482258905Google Scholar

Singh, S, Prakash, C, and Singh, R. (2020). 3D Printing in Biomedical Engineering. Springer Press. ISBN: 978-9811554254Google Scholar

Vogel, HC, Todaro, CC, and Press, WA. (2014). Fermentation and Biochemical Engineering Handbook: Principles, Process Design, and Equipment, 3rd ed. Noyes Publications. ISBN: 978-1455725533Visit https://shreefalmehta.com/csbtbook for additional enriching readings around the topics covered in the book, topical updates on the content and for industry viewpoints and news.Google Scholar