Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

1st Edition - June 27, 2013

Write a review

  • Editors: Lisa Plitnick, Danuta Herzyk
  • Hardcover ISBN: 9780123948106
  • eBook ISBN: 9780123948236

Purchase options

Purchase options
Available
DRM-free (PDF, Mobi, EPub)
Sales tax will be calculated at check-out

Institutional Subscription

Free Global Shipping
No minimum order

Description

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.

Key Features

  • 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

Readership

Pharmaceutical scientists, toxicologists, geneticists, biochemists, cell biologists and immunologists working in the area of biologics within academia, small biotechnology and large pharmaceutical companies.

Table of Contents

  • 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

Product details

  • No. of pages: 432
  • Language: English
  • Copyright: © Academic Press 2013
  • Published: June 27, 2013
  • Imprint: Academic Press
  • Hardcover ISBN: 9780123948106
  • eBook ISBN: 9780123948236

About the Editors

Lisa Plitnick

Affiliations and Expertise

PhD, Merck Research Laboratories, Merck and Co., Inc., West Point, PA

Danuta Herzyk

Affiliations and Expertise

PhD, Merck Research Laboratories, Merck and Co., Inc., West Point, PA

Ratings and Reviews

Write a review

There are currently no reviews for "Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics"