title: Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers.
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.
authors.affiliation: PATH, Seattle, WA 98109, USA.
authors.forename: Rahnuma
authors.initials: R
authors.lastname: Wahid
authors.affiliation: PATH, Seattle, WA 98109, USA.
authors.forename: Renee
authors.initials: R
authors.lastname: Holt
authors.affiliation: Global Project Services, Sanibel, FL 33957, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Hjorth
authors.affiliation: PATH, Seattle, WA 98109, USA. Electronic address: fberlanda-scorza@path.org.
authors.forename: Francesco
authors.initials: F
authors.lastname: Berlanda Scorza
mesh_terms: D002986:Clinical Trials as Topic; D003906:Developing Countries; D006801:Humans; D007252:Influenza Vaccines / Q000737:chemistry* / Q000592:standards / Q000600:supply & distribution; D007251:Influenza, Human / Q000517:prevention & control*; D058873:Pandemics / Q000517:prevention & control*; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000458:organization & administration* / Q000639:trends; D014481:United States; D014483:United States Dept. of Health and Human Services; D014944:World Health Organization
chemical_list: D007252:Influenza Vaccines
keywords: Clinical trial implementation; Influenza vaccine manufacturing; Quality management systems