Editors:
- Provides wide coverage of step-by-step development strategies for engineering antibodies
- Brings together top-tier experts who provide case studies to facilitate development of biopharmaceutical drug device products
- One stop shopping” for the latest information and knowledge of the advances made over last few years in development and manufacturing of a biopharmaceutical combination product
Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series (AAPS, volume 35)
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Table of contents (36 chapters)
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Front Matter
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Drug Product Development
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Front Matter
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About this book
With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).
Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.
The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.
Keywords
- engineered anitbodies
- drug discovery
- combination drug-device products
- New modalities, mAbs, ADC, Bites, CAR-T, DVD, Dualbodies, mRNA
- Molecular assessment and preformulation
- Monoclonal antibodies
- Multi-attribute Method (MAM)
- Biotherapeutics
- Therapeutic Antibody Discovery
- Bispecfic Antibodies
- Combination Drug product
- Protein Therapeutics
- Screening Excipients
Editors and Affiliations
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Formulation Development New Biological Entities, AbbVie (United States), North Chicago, USA
Feroz Jameel
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Drug Product Development (Retired), AbbVie (United States), North Chicago, USA
John W. Skoug
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Combination Product Development, AbbVie, Inc., North Chicago, USA
Robert R. Nesbitt
About the editors
John Skoug has more than 30 years of pharmaceutical industry experience and specializes in CMC product development across all stages of discovery and development. Through early 2019, he was Senior Director in AbbVie’s drug product R&D organization, where he held a number of roles including head of preformulation, solid-oral formulation development, drug/device combination product development and CMC program management. In these roles, he was responsible for CMC technical strategy and execution for small molecule programs and combination product programs for biologics. Prior to AbbVie, John held similar scientific and leadership positions in Pharmaceutical R&D in Upjohn/Pharmacia/Pfizer. John founded FarmCMC LLC in 2019 to leverage his technical and leadership expertise to help small and medium sized biopharmaceutical companies develop novel therapeutic assets and delivery systems through early and late stage development. John received a Ph.D. in Analytical Chemistry from Purdue University, has more than 20 publications and presentations, and has served in various capacities with the American Association of Pharmaceutical Scientists, the Combination Product Coalition, and the IQ Consortium, where he was recognized with the Outstanding Service award in 2015.
Robert Nesbitt is a group leader in Human Factors and Drug Delivery System development in AbbVie’s Combination Product Development group in Lake County, IL. Bob has a BS in Engineering Operations from Iowa State University, and an MBA from the University of Chicago. He joined AbbVie in January 2015, after 16 years at Eli Lilly and Company, where he drove patient-centered design into device development, and where he supported the design and launch of nine different Lilly devices still in use today around the world. Prior to Lilly, Bob led process engineering and manufacturing for both Roche Diagnostics’ blood glucose monitoring and Baxter Healthcare’s Custom Sterile Procedure pack businesses. He has been active in the development of ISO standards for medical devices since 1999; is the US Technical Advisory Group (TAG) co-chair for AAMI’s ISO/TC76 and TC84 committees and has been Convenor of multiple working groups. He holds a patent for inhaled drug delivery device design, and has received Lilly’s “Changing the World” award (2001), “President’s Award” (2006) and was recognized as one of Lilly’s “Top 100 Innovators” (2014).
Bibliographic Information
Book Title: Development of Biopharmaceutical Drug-Device Products
Editors: Feroz Jameel, John W. Skoug, Robert R. Nesbitt
Series Title: AAPS Advances in the Pharmaceutical Sciences Series
DOI: https://doi.org/10.1007/978-3-030-31415-6
Publisher: Springer Cham
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: American Association of Pharmaceutical Scientists 2020
Hardcover ISBN: 978-3-030-31414-9Published: 14 March 2020
Softcover ISBN: 978-3-030-31417-0Published: 26 August 2021
eBook ISBN: 978-3-030-31415-6Published: 13 March 2020
Series ISSN: 2210-7371
Series E-ISSN: 2210-738X
Edition Number: 1
Number of Pages: XVIII, 893
Number of Illustrations: 46 b/w illustrations, 256 illustrations in colour