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Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers
- Source :
- Vaccine. 34(45):5430-5435
- Publication Year :
- 2016
- Publisher :
- Elsevier BV, 2016.
-
Abstract
- With the support of the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services, PATH has contributed to the World Health Organization’s (WHO’s) Global Action Plan for Influenza Vaccines (GAP) by providing technical and clinical assistance to several developing country vaccine manufacturers (DCVMs). GAP builds regionally based independent and sustainable influenza vaccine production capacity to mitigate the overall global shortage of influenza vaccines. The program also ensures adequate influenza vaccine manufacturing capacity in the event of an influenza pandemic.Since 2009, PATH has worked closely with two DCVMs in Vietnam: the Institute of Vaccines and Medical Biologicals (IVAC) and VABIOTECH. Beginning in 2013, PATH also began working with Torlak Institute in Serbia; Instituto Butantan in Brazil; Serum Institute of India Private Ltd. in India; and Changchun BCHT Biotechnology Co. (BCHT) in China.The DCVMs supported under the GAP program all had existing influenza vaccine manufacturing capability and required technical support from PATH to improve vaccine yield, process efficiency, and product formulation. PATH has provided customized technical support for the manufacturing process to each DCVM based on their respective requirements.Additionally, PATH, working with BARDA and WHO, supported several DCVMs in the clinical development of influenza vaccine candidates progressing toward national licensure or WHO prequalification. As a result of the activities outlined in this review, several companies were able to make excellent progress in developing state-of-the-art manufacturing processes and completing early phase clinical trials. Licensure trials are currently ongoing or planned for several DCVMs.
- Subjects :
- Quality Control
Influenza vaccine
030231 tropical medicine
Developing country
World Health Organization
03 medical and health sciences
Technical support
0302 clinical medicine
Immunology and Microbiology(all)
Influenza, Human
Pandemic
Humans
Technology, Pharmaceutical
Medicine
030212 general & internal medicine
Influenza vaccine manufacturing
Developing Countries
Pandemics
Human services
Licensure
Clinical Trials as Topic
General Veterinary
General Immunology and Microbiology
business.industry
Public Health, Environmental and Occupational Health
veterinary(all)
United States
Clinical trial implementation
Engineering management
Quality management system
Infectious Diseases
Influenza Vaccines
Action plan
Immunology
Molecular Medicine
United States Dept. of Health and Human Services
business
Quality management systems
Subjects
Details
- ISSN :
- 0264410X
- Volume :
- 34
- Issue :
- 45
- Database :
- OpenAIRE
- Journal :
- Vaccine
- Accession number :
- edsair.doi.dedup.....fadf79e3f78a2eb3defbaa399fa6e479
- Full Text :
- https://doi.org/10.1016/j.vaccine.2016.07.046