Book contents
- Commercializing Successful Biomedical Technologies
- Commercializing Successful Biomedical Technologies
- Copyright page
- Dedication
- Contents
- Preface
- Acknowledgments
- 1 The biomedical device and drug industry and their markets
- 2 Markets of interest and market research steps
- 3 Starting up your company
- 4 Intellectual property and licensing
- 5 New product development (NPD)
- 6 The regulated market: gateway through the FDA
- 7 Manufacturing
- 8 Reimbursement, marketing, sales, and product liability
- Glossary
- Index
- References
7 - Manufacturing
Published online by Cambridge University Press: 03 November 2022
Book contents
- Commercializing Successful Biomedical Technologies
- Commercializing Successful Biomedical Technologies
- Copyright page
- Dedication
- Contents
- Preface
- Acknowledgments
- 1 The biomedical device and drug industry and their markets
- 2 Markets of interest and market research steps
- 3 Starting up your company
- 4 Intellectual property and licensing
- 5 New product development (NPD)
- 6 The regulated market: gateway through the FDA
- 7 Manufacturing
- 8 Reimbursement, marketing, sales, and product liability
- Glossary
- Index
- References
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.
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- Commercializing Successful Biomedical Technologies , pp. 309 - 362Publisher: Cambridge University PressPrint publication year: 2022
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: 978-1498732062CrossRefGoogle Scholar
Davim, JP. (2012). The Design and Manufacture of Medical Devices. Woodhead Publishing. ISBN: 978-1907568725CrossRefGoogle Scholar
Gee, A. (editor). (2009). Cell Therapy: cGMP Facilities and Manufacturing. Springer Press. ISBN: 978-0387895833Google 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.CrossRefGoogle ScholarPubMed
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
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