Establishment of Onderstepoort Veterinary Research institute
1968: Dedicated vaccine facility established 1992: OBP separated from Onderstepoort Veterinary Research institute 2000: OBP incorporated as a State-owned commercial entity 2007: Achieved ISO 9001 certification. 2012: Obtained funding for upgrading and modernizing the facility into a GMP plant
Public good vaccine - To ensure that the government’s responsibility in terms of food security and safety is met through the development, security and availability of critical vaccine reserves; and
Private good vaccine - Referring to the ability of the organisation to manufacture, distribute and sell vaccines for financial gain
Strategic emergency vaccines - definition Vaccine reserves, antigen banks, emergency vaccine: Vaccine materials ready to be used or ready to be rapidly reconstituted into final vaccine product when needed in emergency
LSD will be used as case study Strategic approaches at OBP
Bottled manufactured vaccines Bulk antigens
Bottled manufactured vaccines Disadvantages
Advantages
Availability for immediate use – shipping in days No need for specialized premises to store bottled formulated vaccines Vaccines can be stored in different locations under appropriate conditions and monitoring
Clients prefer stock with complete shelf life duration Prone to incorrect sales and quantities forecasts No compensation for writtenoff stock even if you are a public good commercial stateowned company Limited use in controlling disease in which there is antigenic variation
Bulked vaccine antigen reserve Advantages
Disadvantages
Technology to concentrate and store bulk LSD vaccine antigen is available Vaccine is formulated only upon demand Quality standards are never compromised Production is shortened to 46 weeks Shelf life starts upon formulation of the given batch
Storage duration of bulk vaccine is limited Regular periodic tests mandatory Specialized storage facility and conditions are required Who bears costs for regular quality monitoring, warehousing and logistics? Order tender process – time of great uncertainty; do you formulate or not?
General conclusions on Strategic emergency vaccines
Vaccines need to still be used as “protective” agents during emergencies Legal contracts between client and vaccine manufacturer mandatory Investment in long term bulking technologies and internationally approved standards for rapid quality control tests Epidemiological surveillance to determine circulating disease strains will ensure availability of relevant emergency vaccine strains.
through the development, security and availability of critical vaccine reserves ... Availability for immediate use. â shipping in days ... monitoring. Disadvantages.
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