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Nonclinical Development of Biologics, Vaccines and Specialty Biologics
- 2nd Edition - October 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
Section I: Development of Biopharmaceuticals
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
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: October 1, 2024
- Imprint: Academic Press
- Hardback ISBN: 9780443133442
LP
Lisa Plitnick
Dr. Lisa Plitnick received a BA in Biology from The State University of New York at Oswego and an MS and a PhD in Immunology from the Albany Medical College in Albany, New York. In 2002, she joined the Department of Safety Assessment and Laboratory Animal Resources in Merck Research Laboratories where she worked as a Study Director and currently serves as the Preclinical Safety Lead on drug development teams and as the Therapeutic Area Lead for Vaccines. She is the Scientific and Regulatory Advisor for the In Vivo Biologics Release Testing Group in the Merck Manufacturing Division and the Scientific Advisor for the Immunotoxicology Laboratory. Dr. Plitnick has edited a book, contributed to several book chapters on biologics and vaccines, and peer-reviewed journal articles. She is a member of the HESI ILSI Immunotoxicology Technical Committee, the BioSafe Specialty Biologics Expert and MoA/MoT working groups, and the Merck Immunotoxicology Council.
Affiliations and expertise
Merck Research Laboratories, Merck and Co., Inc., West Point, PA, USACF
Claudette LaTonya Fuller
Dr. Claudette (Tonya) 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 currently serves as a Therapeutic Area Leader for Infectious Disease at Merck Research Laboratories in West Point, Pennsylvania, USA.
As Therapeutic Area Leader, she is responsible for overseeing the nonclinical development of antibacterial and antifungal programs within the Infectious Disease Therapy Area at Merck where is she is also the co-chair of the ImmunoTox and Biologics Advisory Council that provides expert opinion to all stages of drug discovery and development programs. She is a proven leader in the nonclinical drug development in multiple therapeutic areas (Biologics, Immunology, Immuno-Oncology, Virology, and Anti-Bacterials). She enjoys building and leading diverse and inclusive nonclinical drug safety/operations teams to strategically advance the development of innovative therapeutics.
Affiliations and expertise
Therapeutic Area Leader for Infectious Disease, Merck Research Laboratories in West Point, Pennsylvania, USA