Manufacturing DTaP-based combination vaccines: industrial challenges around essential public health tools

ABSTRACT

Introduction: The manufacture of DTP-backboned combination vaccines is complex, and vaccine quality is evaluated by both batch composition and conformance of manufacturing history. Since their first availability, both the manufacturing regulations for DTP combination vaccines and their demand have evolved significantly. This has resulted in a constant need to modify manufacturing and quality control processes.

Areas covered: Regulations that govern the manufacture of complex vaccines can be inconsistent between countries and need to be aligned with the regulatory requirements that apply in all countries of distribution. Changes in product mix and quantities can lead to uncertainty in vaccine supply maintenance. These problems are discussed in the context of the importance of these products as essential public health tools.

Expert commentary: Increasing demand for complex vaccines globally has led to problems in supply due to intrinsically complex manufacturing and regulatory procedures. Vaccine manufacturers are fully engaged in the resolution of these challenges, but currently changes in demand need ideally to be anticipated approximately 3 years in advance due to long production cycle times.

KEYWORDS:

• DTaP combination
• manufacturing
• formulation
• quality control
• supply
• compliance

Declaration of interest

The authors are full-time employees of Sanofi Pasteur (EV) (vaccine manufacturer) and Sanofi Pasteur-MSD (BS); both Sanofi Pasteur and Sanofi-Pasteur-MSD are marketing authorization holders of vaccines evoked in this review. The authors wish to thank Andrew Lane (Lane Medical Writing) for providing editorial support with preparation of the manuscript, funded by Sanofi Pasteur. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Notes

1. In this article ‘valence’ is defined as the antigen(s) needed to induce protection against one disease.

2. Diptheria toxoid, tetanus toxoid, inactivated poliovirus type 1, inactivated poliovirus type 2, inactivated poliovirus type 3, Bordetella pertussis toxoid, Bordetella pertussis filamentous hemaglutinin, tetanus toxoid conjugated Haemophilus influenzae type b PS, recombinant hepatitis B virus surface antigen.

Additional information

Funding

This manuscript was funded by Sanofi Pasteur.