INTRODUCTION

This chapter describes best practices for production, conjugation, and characterization of polysaccharide and glycoconjugate vaccines. It describes key quality attributes at each step of the process and suggests best methods to assess these attributes. The scope of this chapter includes vaccines consisting of one or more purified polysaccharides (such as pneumococcal, meningococcal, and Typhoid Vi vaccines) and components involved in their production, and vaccines consisting of one or more glycoconjugate immunogens in which a saccharide has been covalently attached to a suitable carrier protein. The latter category includes Haemophilus influenzae type b (Hib), meningococcal, and pneumococcal conjugate vaccines. The chapter does not include combination vaccines in which Hib conjugates are combined with unrelated immunogens against diphtheria, tetanus, and pertussis.