PMID- 24923635 OWN - NLM STAT- MEDLINE DCOM- 20141228 LR - 20140701 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 32 IP - 33 DP - 2014 Jul 16 TI - Lessons learned during the development and transfer of technology related to a new Hib conjugate vaccine to emerging vaccine manufacturers. PG - 4124-30 LID - S0264-410X(14)00679-3 [pii] LID - 10.1016/j.vaccine.2014.05.023 [doi] AB - The incidence of Haemophilus Influenzae type b (Hib) disease in developed countries has decreased since the introduction of Hib conjugate vaccines in their National Immunization Programs (NIP). In countries where Hib vaccination is not applied routinely, due to limited availability and high cost of the vaccines, invasive Hib disease is still a cause of mortality. Through the development of a production process for a Hib conjugate vaccine and related quality control tests and the transfer of this technology to emerging vaccine manufacturers in developing countries, a substantial contribution was made to the availability and affordability of Hib conjugate vaccines in these countries. Technology transfer is considered to be one of the fastest ways to get access to the technology needed for the production of vaccines. The first Hib conjugate vaccine based on the transferred technology was licensed in 2007, since then more Hib vaccines based on this technology were licensed. This paper describes the successful development and transfer of Hib conjugate vaccine technology to vaccine manufacturers in India, China and Indonesia. By describing the lessons learned in this process, it is hoped that other technology transfer projects can benefit from the knowledge and experience gained. CI - Copyright (c) 2014 Elsevier Ltd. All rights reserved. FAU - Hamidi, A AU - Hamidi A AD - Institute for Translational Vaccinology, Bilthoven, The Netherlands. Electronic address: ahd.hamidi@intravacc.nl. FAU - Boog, C AU - Boog C AD - Institute for Translational Vaccinology, Bilthoven, The Netherlands. FAU - Jadhav, S AU - Jadhav S AD - Serum Institute of India Limited, Pune, India. FAU - Kreeftenberg, H AU - Kreeftenberg H AD - Institute for Translational Vaccinology, Bilthoven, The Netherlands. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20140609 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Haemophilus Vaccines) RN - 0 (Haemophilus influenzae type b polysaccharide vaccine) RN - 0 (Vaccines, Conjugate) SB - IM MH - Bacterial Capsules MH - China MH - Developing Countries MH - Haemophilus Infections/*prevention & control MH - Haemophilus Vaccines/*economics MH - Haemophilus influenzae type b MH - Humans MH - India MH - Indonesia MH - Meningitis, Haemophilus/prevention & control MH - *Technology Transfer MH - Technology, Pharmaceutical MH - Vaccines, Conjugate/economics OTO - NOTNLM OT - Haemophilus Influenzae type b OT - Lessons learned OT - Technology transfer developing countries vaccine manufacturers OT - Vaccine EDAT- 2014/06/14 06:00 MHDA- 2014/12/30 06:00 CRDT- 2014/06/14 06:00 PHST- 2014/02/24 00:00 [received] PHST- 2014/04/28 00:00 [revised] PHST- 2014/05/01 00:00 [accepted] PHST- 2014/06/14 06:00 [entrez] PHST- 2014/06/14 06:00 [pubmed] PHST- 2014/12/30 06:00 [medline] AID - S0264-410X(14)00679-3 [pii] AID - 10.1016/j.vaccine.2014.05.023 [doi] PST - ppublish SO - Vaccine. 2014 Jul 16;32(33):4124-30. doi: 10.1016/j.vaccine.2014.05.023. Epub 2014 Jun 9.