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

Ch

Details

No. of pages:
432
Language:
English
Copyright:
© 2013
Published:
Imprint:
Academic Press
Print ISBN:
9780123948106
Electronic ISBN:
9780123948236

About the authors

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

Reviews

"…brings nonclinical testing of biological and follow-on biological drugs, vaccines plus cell and gene therapy drugs right up to date. It is written in a very readable, yet highly scientific manner and most of the relevant publications…on the topic are referenced…Overall, a ‘must read’ book for all in the nonclinical field of developing biological drugs."--btsNews, June 2014
"Researchers in pharmaceuticals, toxicology, and other biological sciences summarize the current status of developing medicines from biological material, pointing out where the process is different from developing small-molecule medicines and where it is the same. The topics include regulatory guidelines and their application in the non-clinical evaluation of biological medicines, early de-risking strategy for novel biotherapeutics…"--Reference & Research Book News, December 2013