Development and technology transfer of Haemophilus influenzae type b conjugate vaccines for developing countries |
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Authors: | Beurret Michel Hamidi Ahd Kreeftenberg Hans |
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Affiliation: | Unit Vaccinology, Centre for Infectious Disease Control (CIb), National Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA Bilthoven, The Netherlands. Michel.Beurret@crucell.com |
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Abstract: | This paper describes the development of a Haemophilus influenzae type b (Hib) conjugate vaccine at the National Institute for Public Health and the Environment/Netherlands Vaccine Institute (RIVM/NVI, Bilthoven, The Netherlands), and the subsequent transfer of its production process to manufacturers in developing countries. In 1998, at the outset of the project, the majority of the world's children were not immunized against Hib because of the high price and limited supply of the conjugate vaccines, due partly to the fact that local manufacturers in developing countries did not master the Hib conjugate production technology. To address this problem, the RIVM/NVI has developed a robust Hib conjugate vaccine production process based on a proven model, and transferred this technology to several partners in India, Indonesia, Korea and China. As a result, emerging manufacturers in developing countries acquired modern technologies previously unavailable to them. This has in turn facilitated their approach to producing other conjugate vaccines. As an additional spin-off from the project, a World Health Organization (WHO) Hib quality control (QC) course was designed and conducted at the RIVM/NVI, resulting in an increased regulatory capacity for conjugate vaccines in developing countries at the National Regulatory Authority (NRA) level. For the local populations, this has translated into an increased and sustainable supply of affordable Hib conjugate-containing combination vaccines. During the course of this project, developing countries have demonstrated their ability to produce large quantities of high-quality modern vaccines after a successful transfer of the technology. |
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Keywords: | ADH, adipic acid dihydrazide BE, Biological E. (India) BF, Bio Farma (Indonesia) DCVMN, Developing Countries Vaccine Manufacturers Network DSC, differential scanning calorimetry EP, European Pharmacopeia GAVI, GAVI Alliance (formerly The Global Alliance for Vaccines and Immunization) GMP, Good Manufacturing Practice HbO-HA, PRP oligosaccharide conjugated to human albumin carrier protein HepB, hepatitis B Hib, Haemophilus influenzae type b 1H NMR, proton nuclear magnetic resonance HPSEC, high performance size exclusion chromatography IPV, inactivated polio vaccine MDG, Millennium Development Goals Mr, relative molecular mass NIBSC, National Institute for Biological Standards and Control (UK) NRA, National Regulatory Authority PRP, poly-ribosylribitol phosphate (Hib capsular polysaccharide) PRP-AH, ADH-modified PRP PRP-T, PRP polysaccharide conjugated to TTd carrier protein QC, quality control RI, differential refractive index SII, Serum Institute of India SEC, size exclusion chromatography ToBI, toxin-binding inhibition test tR, retention time TTd, tetanus toxoid UNICEF, United Nations International Children‘s Emergency Fund WHO, World Health Organization |
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