title: Challenges and Opportunities While Developing a Group A Meningococcal Conjugate Vaccine Within a Product Development Partnership: A Manufacturer's Perspective From the Serum Institute of India.
abstract: BACKGROUND
  In 2002, the Meningitis Vaccine Project (MVP) chose the Serum Institute of India, Ltd (SIIL), as its manufacturing partner to establish a product development partnership (PDP) with the Meningitis Vaccine Project (MVP). MVP was a collaboration between PATH and the World Health Organization (WHO) to develop meningococcal conjugate vaccines for sub-Saharan Africa.
  
  
  METHODS
  From the outset, SIIL recognized that a partnership with MVP carried some risk but also offered important opportunities for accessing new conjugate vaccine technology and know-how. Over 3 years, SIIL successfully accepted technology transfer for the group A meningococcal polysaccharide from SynCo Bio Partners and a conjugation method from the US Food and Drug Administration.
  
  
  RESULTS
  SIIL successfully scaled up production of a group A meningococcal conjugate vaccine that used SIIL tetanus toxoid as the carrier protein. Phase 1 studies began in India in 2005, followed by phase 2/3 studies in Africa and India. A regulatory dossier was submitted to the Indian authorities in April 2009 and WHO in September 2009. Export license was granted in December 2009, and WHO prequalification was obtained in June 2010. Vaccine was introduced at public scale in Burkina Faso that December. The group A meningococcal conjugate vaccine was named MenAfriVac, and is the first internationally qualified vaccine developed outside of big pharma.
  
  
  CONCLUSIONS
  The project proved to be a sound investment for SIIL and is a concrete example of the potential for PDPs to provide needed products for resource-poor countries.
authors.affiliation: Serum Institute of India, Ltd, Pune.
authors.forename: Prasad S
authors.initials: PS
authors.lastname: Kulkarni
authors.affiliation: PATH, Geneva, Switzerland.
authors.forename: Muriel
authors.initials: M
authors.lastname: Socquet
authors.affiliation: Serum Institute of India, Ltd, Pune.
authors.forename: Suresh S
authors.initials: SS
authors.lastname: Jadhav
authors.affiliation: Serum Institute of India, Ltd, Pune.
authors.forename: Subhash V
authors.initials: SV
authors.lastname: Kapre
authors.affiliation: Serum Institute of India, Ltd, Pune.
authors.forename: F Marc
authors.initials: FM
authors.lastname: LaForce
authors.affiliation: Serum Institute of India, Ltd, Pune.
authors.forename: Cyrus S
authors.initials: CS
authors.lastname: Poonawalla
mesh_terms: D006801:Humans; D007194:India; D007391:International Cooperation; D022401:Meningococcal Vaccines / Q000276:immunology* / Q000302:isolation & purification*; D018581:Technology Transfer; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000458:organization & administration*; D014944:World Health Organization
chemical_list: C573970:MenAfriVac; D022401:Meningococcal Vaccines
keywords: MenAfriVac; Product Development Partnership; Serum Institute of India Ltd