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Glycoconjugate Vaccines: The Regulatory Framework

  • Christopher JonesEmail author
Part of the Methods in Molecular Biology book series (MIMB, volume 1331)

Abstract

Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine—or vaccines in general—on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.

Key words

Regulatory requirements Quality control World Health Organization Pharmacopeias Batch release 

Abbreviations

(c)GMP

(current) Good manufacturing practice

CPMP

Committee for Proprietary Medicinal Products

CPS

Capsular polysaccharide

EMA

European Medicines Agency

EP

European Pharmacopoeia

EPI

Expanded Programme on Immunization

FDA

Food and Drug Administration

Hib

Haemophilus influenzae type b

HPAEC

High performance anion exchange chromatography

HPLC

High performance liquid chromatography

HPSEC

High performance size exclusion chromatography

ICH

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

IS

International Standards

LAL

Limulus amoebocyte lysate

MALLS

Multiple angle laser light scattering

Men

Meningococcal

NMR

Nuclear magnetic resonance

NRA

National Regulatory Authority

NRL

National Regulatory Laboratory

OCABR

Official Control Authority Batch Release

Pn

Pneumococcal

s.h.d.

Single human dose

SI

Système International d’Unités

TRS

WHO Technical report series

USP

United States Pharmacopeia

WHO

World Health Organization

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Copyright information

© Springer Science+Business Media New York 2015

Authors and Affiliations

  1. 1.Laboratory for Molecular StructureNational Institute for Biological Standards and ControlHertfordshireUK

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