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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
1st Edition - June 27, 2013
Editors: Lisa Plitnick, Danuta Herzyk
Hardback ISBN:
9 7 8 - 0 - 1 2 - 3 9 4 8 1 0 - 6
eBook ISBN:
9 7 8 - 0 - 1 2 - 3 9 4 8 2 3 - 6
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel… Read more
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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. 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. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all 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"
- A multi-authored book with chapters written by qualified experts in their respective fields
Dedication
Preface
Contributors
Acknowledgments
Section I: Development of Biopharmaceuticals Defined as Novel Biologics
Chapter 1. Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development
Introduction
History and Evolution of Biopharmaceuticals
Development of Diverse Biopharmaceutical Modalities
Comparison of Small-Molecule Drugs to Biopharmaceuticals
Summary
References
Chapter 2. Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines
Introduction
Species Selection
Study Design Considerations for Repeat-Dose Studies
Immunogenicity
Reproductive and Developmental Toxicity
Genotoxicity and Carcinogenicity
Special Considerations for Anticancer Drugs
First-in-Human (Fih) Clinical Trial
Summary
References
Chapter 3. Early De-risking Strategy for Novel Biotherapeutics
Introduction
Establishing A Safety Profile for Biotherapeutics
General Safety Considerations Related to Biotherapeutics
Progress in Evaluation of Immunotoxicity
Can We Better Address Potential Off-Target Toxicity?
Summary
References
Chapter 4. Novel Biopharmaceuticals: Pharmacokinetics, Pharmacodynamics, and Bioanalytics
Introduction
Absorption, Distribution and Elimination of Biopharmaceuticals
Disposition of Modified Molecules
“Metabolism” and Biodistribution for Biopharmaceuticals
Immunogenicity and impacts on PK and biodistribution
Pharmacokinetics and Pharmacodynamics
Preclinical to Clinical Translation
Bioanalytics
Drug Assays
Biomarkers: Target Engagement Assays
Immunogenicity Assessment: ADA Assays
Summary
References
Section II: Development of Biosimilars
Chapter 5. Overview of Biosimilar Therapeutics
Introduction
The Concept of Biosimilars
General Considerations for Development of Biosimilars
Biosimilar Candidates Based on Modality and Therapeutic Class
Summary
References
Chapter 6. Regulatory Standards for the Approval of Biosimilar Products: A Global Review
Introduction
European Union—Pioneer for the First Regulatory Pathway for Biosimilar Products
The World Health Organization Guidance on Biosimilars
Regulatory Pathway for Biosimilar Products in the United States
Biosimilar Pathways in Other Regions
Summary
References
Chapter 7. Early Characterization of Biosimilar Therapeutics
Introduction
Recombinant Insulins
Recombinant Human Growth Hormone
Recombinant Erythropoietins
Recombinant Granulocyte Colony-Stimulating Factor
Recombinant Interferons
Low Molecular Weight Heparins
Monoclonal Antibodies
Other Classes
Summary
References
Section III: Vaccines
Chapter 8. Introduction to Vaccines and Adjuvants
Introduction
The History of Vaccines
The Impact of Vaccines on Human Health
Advancements in Vaccines Technologies
Advancements in Adjuvant Technologies
Approved Infectious Disease Vaccines and Diseases for Which Preventive Vaccines are Still Needed
Therapeutic Vaccines
Product Complexity From A Quality Perspective
Nonclinical Testing
Clinical Testing
Vaccine Development Using the Animal Rule
The Anti-Vaccines Movement and Misperceptions About Vaccines and Their Safety
Summary
References
Chapter 9. Global Regulatory Guidelines for Vaccines
Introduction
Toxicity Assessment
Additional Toxicity Assessments
Special Considerations
Formulation/Delivery Devices
Alternate Routes of Administration
Special Considerations for Particular Types of Vaccines
Summary
References
Chapter 10. Special Considerations for the Nonclinical Safety Assessment of Vaccines
Introduction
De-risking Strategies for Vaccines
Pharmacokinetics and Pharmacodynamics Assessments
Differences in the Nonclinical Safety Assessment of Vaccines and Biopharmaceutical Drugs
Summary
References
Section IV: Specialty Biologics and Indications
Chapter 11. Turning the Corner with Viral-based Gene Therapy—Development of the Rogue Biopharmaceutical
Introduction
A History and Primer of Gene Therapy
The Process of Getting Genes into Cells
Health Authority Regulation of Gene Therapy Products
Nonclinical Safety Studies and Regulatory Guidance
Summary
References
Chapter 12. Blood Products
Introduction
Plasma-Derived Blood Products
Blood Products Derived from Recombinant Technologies
Summary
References
Chapter 13. Biological Therapies for Cancer
Introduction
Global Regulatory Guidances
General Principles of Toxicology Assessments
Nonclinical Studies and Principles of Study Design
Specialty Toxicology Assessments
Pharmacokinetics, Immunogenicity, and Pharmacodynamics
Nonclinical Development of Marketed Biologics
Recombinant Analogs of Endogeneous Human Proteins (Interferons, Cytokines, Enzymes)
Summary
References
Chapter 14. Nonclinical Development of Multi-targeting Biopharmaceuticals
Introduction
Scientific Rationale for Multi-Targeting Biopharmaceuticals (MTBs)
Evolution of Technology Platforms
General Challenges and Considerations
Summary of Challenges
T Cell–Dependent Bispecific Antibody (TDB) Biotherapeutics
Dual-Targeting Antibodies
Summary
References
Chapter 15. Considerations in the Development of Pluripotent Stem Cell-based Therapies
Introduction
Early Decisions
NONclinical Development
Translating Preclinical Data to Clinical Application
Global Regulatory Guidance
Summary
References
Color Plates
Index
- No. of pages: 432
- Language: English
- Published: June 27, 2013
- Imprint: Academic Press
- Hardback ISBN: 9780123948106
- eBook ISBN: 9780123948236
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, USADH
Danuta Herzyk
Affiliations and expertise
PhD, Merck Research Laboratories, Merck and Co., Inc., West Point, PA