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Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies - 1st Edition - ISBN: 9780124166035, 9780124166615

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies

1st Edition

Editors: Manmohan Singh Maya Salnikova
Hardcover ISBN: 9780124166035
eBook ISBN: 9780124166615
Imprint: Academic Press
Published Date: 30th December 2014
Page Count: 520
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Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel approaches to the treatment of cancer, immunotherapy and more. It includes real-world cases and examples which highlight formulations with therapeutic proteins, monoclonal antibodies, peptides and biobetters, as well as cases on novel vaccines formulations including evolving pathogens, novel modalities of vaccines, universal vaccines. This book is a thorough and useful resource on the development of novel biologics, vaccines and cancer therapies.

Key Features

  • Provides strategies for the development of safe and efficacious novel formulations for various modalities of biologics, vaccines and for cancer therapy
  • Highlights novel cases from current clinical trials as well as marketed products
  • Reviews overall successes and challenges in the development of novel formulations, including new molecular targets for the treatment of diseases, design of target-specific therapies, regulatory considerations, individualized therapies


Researchers, clinicians and students working in formulation, drug delivery, biotechnology, oncology, personalized medicine, immunology, parenteral devices and systems and molecular biology

Table of Contents

  • List of Contributors
  • Preface
  • Section I: Novel therapeutic approaches
    • Chapter 1: Clinical Considerations in the Design, Evaluation, and Development of Novel Therapies
      • Abstract
      • Introduction
      • Scientific challenges in the design of effective pharmacological and biological compounds
      • Changes in the current landscape of clinical development evaluation for novel therapies
      • Influencing and changing the status quo: considerations in the clinical development of future therapies
    • Chapter 2: New Era in Gene Therapy
      • Abstract
      • Introduction
      • Non-viral vectors
      • Viral vectors
      • Genomics and epigenomics in drug discovery
      • Clinical trials
      • Conclusion and future prospects
    • Chapter 3: Advances in Nanotechnology-Based Drug Delivery Platforms and Novel Drug Delivery Systems
      • Abstract
      • Introduction to Nanomedicine
      • Strategies for preferential accumulation of nanoparticles
      • Next-generation drug delivery platforms
      • Implants
    • Chapter 4: Novel Approaches for the Delivery of Biologics to the Central Nervous System
      • Abstract
      • The rising global burden of central nervous system disorders
      • Challenges in CNS drug development
      • Clinical strategies in CNS delivery for overcoming the blood–brain barrier
      • New directions in CNS delivery
      • Conclusion
    • Chapter 5: Trends in Nonparenteral Delivery of Biologics, Vaccines and Cancer Therapies
      • Abstract
      • Introduction
      • Formulation aspects of biologics and vaccines
      • Routes for administration of biologics, vaccines, and cancer therapies
      • Chemotherapy versus immunotherapy
      • Current immune therapies
      • Combination of immunotherapy and chemotherapy
      • Microparticle-based delivery systems for nonparenteral delivery of bacterial (meningococcal) vaccines
      • Influenza vaccine
      • Human papillomavirus vaccine
      • Cancer vaccine case studies
      • Overall summary and conclusions
  • Section II: Novel approaches for biologics
    • Chapter 6: Novel Generation of Antibody-Based Therapeutics
      • Abstract
      • Introduction
      • IgG structure
      • Generation and selection of antibody V-regions
      • Engineering fit-for-purpose antibody-based therapeutics
      • Conclusions
    • Chapter 7: Novel Approaches in Discovery and Design of Antibody-Based Therapeutics
      • Abstract
      • Introduction
      • Antibody discovery and optimization via data mining
      • Species other than humans and rodents as source of V regions
      • Bi- and multispecifics inspired in the modularity of antibodies
      • Conclusions
      • Acknowledgments
    • Chapter 8: Novel Therapeutic Proteins and Peptides
      • Abstract
      • Introduction
      • Innovation in recombinant therapeutic proteins and peptides
      • Innovation in synthetic therapeutics peptides
      • Novel opportunities for biologics
    • Chapter 9: Biobetter Biologics
      • Abstract
      • Introduction
      • Emerging trends in developing biobetter biologics
      • Manufacturing process improvements
      • Conclusions
      • Acknowledgments
  • Section III: Novel approaches for vaccines
    • Chapter 10: Vaccines Against Non-Infectious, Non-Cancer Novel Targets
      • Abstract
      • Overview of non-infectious, non-cancer vaccine targets
      • Reproductive system
      • Neuroendocrine system
      • Immune system
      • Future trends
      • Conclusions
    • Chapter 11: Winning a Race Against Evolving Pathogens with Novel Platforms and Universal Vaccines
      • Abstract
      • Seasonal and pandemic influenza vaccines
      • Human immunodeficiency virus vaccines
      • Dengue vaccines
      • Streptococcus pneumoniae vaccines
      • Development of novel adjuvants
    • Chapter 12: Prime-Boost Vaccination: Impact on the HIV-1 Vaccine Field
      • Abstract
      • Introduction
      • Immunity to HIV-1
      • Landscape of HIV-1 vaccines
      • Principles of prime-boost vaccination
      • DNA prime-boost strategies
      • Pox viral prime-boost strategies
      • Other viral vector prime-boost vaccination strategies
      • Mucosal immunity and prime-boost vaccination approaches
      • Importance of HIV-specific T- and B-cell avidity and novel HIV-1 prime-boost vaccination strategies
      • Conclusions
  • Section IV: Novel approaches for cancer therapies
    • IV.I: Novel Therapeutic Approaches and Targets for Cancer
      • Chapter 13: Personalized Therapies for Cancer Treatment
        • Abstract
        • Introduction
        • The Cancer Genome Atlas
        • High-throughput technologies
        • Using targeted therapy to personalize cancer treatment
        • Personalized therapy for breast cancer: are we there yet?
      • Chapter 14: Hunting Molecular Targets for Anticancer Reagents by Chemical Proteomics
        • Abstract
        • Introduction
        • Chemical proteomics strategies
        • Chemical proteomic-based quantification
        • Systematic and Efficacious Target Identification
        • Conclusions
    • IV.II: Novel Immunotherapies for Cancer
      • Chapter 15: Cancer Vaccines
        • Abstract
        • Introduction
        • Limited potency of cancer vaccines
        • Vaccine platforms
        • Limited clinical efficacy of cancer vaccines
        • New trends in vaccine strategies
        • Summary
      • Chapter 16: T-Cell Immunotherapy for Cancer
        • Abstract
        • Brief history of T-cell therapy
        • Tumor-infiltrating lymphocytes
        • Antigen-Specific T cells
        • Genetically modified T Cells
        • Challenges in T-cell immunotherapies
        • Summary
      • Chapter 17: Immunostimulators and Immunomodulators in Cancer Treatment
        • Abstract
        • Cytokines and cancer therapy
        • Oncolytic viruses
        • Checkpoint inhibitors
        • Importance of the Th1/Th2 response in cancer immunotherapy
    • IV.III: Novel Approaches for Cancer Therapy with Small Molecules
      • Chapter 18: Long-Circulating Therapies for Cancer Treatment
        • Abstract
        • Introduction: consideration of nanotechnology for cancer therapy
        • Challenges in rational design of nanocarriers: longevity in the blood as an important basic property of colloidal drug delivery systems
        • Approaches to designing long-circulating nanoparticles
        • Enhancing efficacy of PEGylated nanoparticles: sheddable coatings
        • Conclusion
        • Acknowledgments
      • Chapter 19: Recent Advances and Trends in the Brain Delivery of Small Molecule Based Cancer Therapies
        • Abstract
        • Introduction
        • Liposomes for the delivery of chemotherapeutics
        • Targeted delivery of liposomal chemotherapeutics to brain tumors
        • Practical issues in the development of liposomal formulations of chemotherapeutic drugs
        • Conclusions and recommendations
  • Index


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© Academic Press 2015
30th December 2014
Academic Press
Hardcover ISBN:
eBook ISBN:

About the Editors

Manmohan Singh

Manmohan Singh, Ph.D. is a well-known expert in the area of vaccine formulations and adjuvant research and has been working in vaccine R&D for the last 20 years. He has authored over 120 peer reviewed manuscripts, review articles and book chapters in this area. Dr. Singh is on the editorial board of 9 International Journals . He is also the editor of several books on vaccine delivery systems and adjuvants. He is currently working as the Head of Global Drug Product Development at Novartis Vaccines in Holly Springs, NC, U.S.A.

Affiliations and Expertise

PhD, Head of Global Manufacturing Technology Development & Adjuvant Formulation & Technology, Novartis Vaccines and Diagnostics; Adjunct Professor, University of North Carolina at Chapel Hill

Maya Salnikova

Maya Salnikova, Ph.D. is a well-known expert in the area of biologics, biosimilars and vaccine formulations. She has been working on development of novel formulations for the past 10 years in academia and industry. She has authored over 20 peer reviewed articles and book chapters. Dr. Salnikova is on the board of reviewers for Journal of Pharmaceutical Sciences and has contributed in organizing of international conferences. She is currently working as Drug Product Development Lead at Novartis Vaccines in Holly Springs, NC, U.S.A.

Affiliations and Expertise

PhD, Principal Scientist and Formulation Group Leader, Novartis Vaccines and Diagnostics, Holly Springs, NC

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