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Nonclinical Development of Biologics, Vaccines and Specialty Biologics
- 2nd Edition - November 1, 2024
- Editors: Lisa Plitnick, Claudette LaTonya Fuller
- Language: English
- Hardback ISBN:9 7 8 - 0 - 4 4 3 - 1 3 3 4 4 - 2
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 1 3 3 4 5 - 9
Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel… Read more
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Request a sales quoteNonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies, and blood products. Updated and revised, the new edition compares and contrasts these types of biologics with one another, and with small molecule drugs while incorporating the most current and essential international regulatory guidelines. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays.
This multi-edited book with chapters authored by leading qualified experts in the field offers a comprehensive reference on critical insights that will be of interest to researchers involved in early through late-stage biologics.
- Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical
- Contains the most pertinent international regulatory guidance documents for nonclinical evaluation
- Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars"
- Updated and revised, with new chapters on nonclinical development of monovalent and polyvalent biopharmaceuticals; pharmacokinetics, pharmacodynamics, and bioanalytics; regulatory expectations and early characterization of biosimilar therapeutics; and cell and gene therapies
Pharmaceutical scientists, pharmaceutical toxicologists, geneticists, biochemists, cell biologists, and immunologists working in the area of biologics within academia, small biotechnology, and large pharmaceutical companies, Regulatory Affairs Professionals, Manufacturers, Graduate students, and Postdocs
1. Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development
2. Nonclinical Development of Monovalent and Polyvalent Biopharmaceuticals
3. Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines
4. Early De-risking Strategy for Novel Biotherapeutics
5. Pharmacokinetics, Pharmacodynamics, and Bioanalytics
6. Overview, Regulatory Expectations and Early Characterization of Biosimilar Therapeutics
Section II: Vaccines
7. Introduction to Vaccines and Adjuvants
8. Global Regulatory Guidelines for Vaccines
9. Special Considerations for the Nonclinical Safety Assessment of Vaccines
Section III: Specialty Biologics and Indications
10. Gene Therapy
11. Cell Therapy
12. Biological Therapies for Cancer
13. Considerations in the Development of Pluripotent Stem Cell-based Therapies
- No. of pages: 450
- Language: English
- Edition: 2
- Published: November 1, 2024
- Imprint: Academic Press
- Hardback ISBN: 9780443133442
- eBook ISBN: 9780443133459
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Lisa Plitnick
Dr. Lisa M. Plitnick is a Distinguished Scientist in Nonclinical Drug Safety, Merck Research Laboratories, Merck and Co., Inc. Lisa joined Merck in 2002 and currently serves as the Therapeutic Area Lead for Vaccines and a Nonclinical Safety Lead on vaccine and biologic development teams spanning early and late development. Lisa is also the Scientific and Regulatory Advisor for the in Vivo Biologics Release Testing Group in the Merck Manufacturing Division. Lisa co-edited Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics, the first edition of this book and has written and/or contributed to book chapters and peer-reviewed journal articles on biologics and vaccines. Lisa received a M.S. and Ph.D. in Immunology from the Albany Medical College. Following her graduate work she did a postdoctoral fellowship with a focus on Immunotoxicology in the Curriculum in Toxicology at the University of North Carolina in cooperation with the US Environmental Protection Agency, Dow Chemical and DuPont.
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Claudette LaTonya Fuller
Dr. Claudette Fuller completed her PhD in Viral Immunology at the University of Virginia. She completed postdoctoral work at the University of Texas Medical Branch and National Cancer Institute - National Institutes of Health, focusing on molecular immunology. She was previously an Immunotoxicology and Nonclinical Lead at GSK, and more recently, a Therapeutic Area Leader for the Immunology and Infectious Disease Portfolios at Merck Research Laboratories, Merck and Co., Inc. At Merck, she was also the nonclinical lead on immuno-oncology biologics in all stages of development. She is currently Vice President, Global Head of Non-Clinical Safety & Toxicology at Genmab where she leads a global team in the development of oncology and immunology biologics.