Carbohydrate-Based Vaccines

From Concept to Clinic

Edited by A. Krishna Prasad

ACS Symposium Series

A useful reference into the design, development, manufacturing, and licensure of glycoconjugate vaccine development

Carbohydrate-Based Vaccines

From Concept to Clinic

Edited by A. Krishna Prasad

Description

The past three decades have witnessed the development and regulatory approval of glycoconjugate vaccines against several medically important bacterial pathogens, including Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitides, and Salmonella typhi. Immunologic protection against these and many other bacterial diseases is mediated through opsonophagocytic antibodies directed against the surface carbohydrates that define the bacterial serogroup or serotype and serve as virulence factors. These vaccines are composed of bacterial capsular polysaccharides chemically conjugated to immunogenic carrier proteins. Given that the diseases caused by these bacterial pathogens are most pronounced in infants and young children, the development of the glycoconjugate vaccine technology has had a considerable impact on public health.
Many of the chapters in this volume were assembled as a follow-up from a symposium entitled "Carbohydrate-Based Vaccines and Adjuvants" which took place at the 254th American Chemical Society National Meeting held in Washington, DC (August 2017). The symposium was sponsored by Pfizer and the Carbohydrate (CARB) and Biotechnology (BIOT) divisions. This book, therefore, reflects the importance of this field toward design, development, manufacture and licensure of the complex carbohydrate-based (glycoconjugate) vaccines.
The book has been organized into thirteen chapters, which cover a comprehensive landscape including the clinical history, design, development, chemistry, manufacturing and control (CMC) aspects, pre-clinical assays, adjuvants and the various approaches used to develop carbohydrate-based vaccines.

Carbohydrate-Based Vaccines

From Concept to Clinic

Edited by A. Krishna Prasad

ACS Symposium Series

Dedication
Foreword
1. Introduction
2. Glycoconjugate Vaccines: The Clinical Journey
3. Immunological Mechanisms of Glycoconjugate Vaccines
4. Design and Development of Glycoconjugate Vaccines
5. Manufacturing Considerations for Glycoconjugate Vaccines
6. Multivalent Meningococcal Conjugate Vaccines: Chemical Conjugation Strategies Used for the Preparation of Vaccines Licensed or in Clinical Trials
7. The Role of Molecular Modeling in Predicting Carbohydrate Antigen Conformation and Understanding Vaccine Immunogenicity
8. Advances in Synthetic Approaches towards Glycoantigens
9. Formulation Development of Glycoconjugate Vaccines for Low- and Middle-Income Countries
10. Preclinical Assessment of Glycoconjugate Vaccines
11. Campylobacter jejuni Capsule Polysaccharide Conjugate Vaccine
12. Chemistry Manufacturing, Control, and Licensure for Carbohydrate-Based Vaccines
13. Lessons Learned and Future Challenges in the Design and Manufacture of Glycoconjugate Vaccines
Editor's Biography
Author Index
Subject Index

Carbohydrate-Based Vaccines

From Concept to Clinic

Edited by A. Krishna Prasad

ACS Symposium Series

Author Information

Edited by A. Krishna Prasad, Director of Early Phase Vaccine Development, Pfizer

Dr. Krishna Prasad functioned as the Director of Vaccine Research and Development, at Pfizer. Dr. Prasad is a recognized industry leader in Vaccine Development and founder of Citranvi, LLC a pre-clinical stage Vaccines R & D company. He joined Wyeth-Lederle Vaccines and Pediatrics in 1998, which later became Pfizer. He has been named as an inventor or co-inventor in more than 150 granted patents world-wide, which played a significant role towards the development and protection of Pfizer's diverse conjugate vaccine intellectual property portfolio. During his 20 years tenure at Wyeth/Pfizer, he successfully led many innovative and complex multi-component vaccine candidates through all stages of pre-clinical and clinical development through commercial licensure, notably Pneumococcal conjugate vaccine (Prevnar-13®), meningococcal (Meningitec®); and many clinical candidates such as staphylococcal, Group B Streptococcus (GBS) Respiratory Syncytial Virus (RSV) and A-?-Peptide-CRM197 conjugate

immunotherapeutic against Alzheimer's Disease. Dr. Prasad is an expert in design, research, early and late phase clinical development, scale-up, technology transfer, clinical trial material manufacturing under cGMP, trouble-shooting and commercialization of vaccines. He obtained his Ph. D. in Medicinal Chemistry of Natural Products from Central Drug Research Institute, Lucknow, India. After postdoctoral stints at University of Rhode Island and Case Western Reserve University he served as Asst. Research Officer at the National Research Council Canada.

Contributors:

A. Krishna Prasad
Stephen P. Lockhart
Daniel A. Scott
Kathrin U. Jansen
Annaliesa S. Anderson
William C. Gruber
Jeremy A. Duke
Fikri Y. Avci
Jin-hwan Kim
Jianxin Gu
Kent Murphy
Stephen A. Kolodziej
Francesco Berti
Michelle M. Kuttel
Neil Ravenscroft
A. R. Vartak
S. J. Sucheck
Lakshmi Khandke
Jo Anne Welsch
Mark R. Alderson
Ingrid L. Scully
Kena A. Swanson
Isis Kanevsky
Annaliesa S. Anderson
Mario A. Monteiro
Alexander Noll
Renee M. Laird
Brittany Pequegnat
Zuchao Ma
Lisa Bertolo
Christina DePass
Eman Omari
Pawel Gabryelski
Olena Redkyna
Yuening Jiao
Silvia Borrelli
Frederic Poly
Patricia Guerry
Christopher Jones
John P. Hennessey, Jr.
Paolo Costantino
Philippe Talaga
Michel Beurret
Neil Ravenscroft
Mark R. Alderson
Earl Zablackis
Carl Frasch