The University of Cape Town Vaccine Research Group's good laboratory practice (GLP) facility, used to test vaccines, has passed the South African National Accreditation System's (SANAS) six-month inspection with flying colours, good news for the laboratory, which was certified GLP-compliant in January this year.
Part of the Institute of Infectious Disease and Molecular Medicine (IID), it is the only laboratory at the university that is compliant with the Organisation for Economic Cooperation and Development (OECD) good laboratory practice.
The endorsement is an important one. The University of Cape Town Vaccine Research Group (UCTVRG) is part of the South African AIDS Vaccine Initiative (SAAVI)- funded HIV Vaccine Development Group at UCT, which is developing HIV-1 subtype C vaccines in the country.
The HIV Vaccine Development Group has developed two candidate vaccines for clinical trial testing in the US and South Africa. The first of these, the DNA vaccine, SAAVI DNA-C, has been commercially manufactured overseas.
Before this vaccine can enter clinical trials scheduled for 2006, however, it must conform to both the Medicines Control Council in South Africa and the US Food and Drug Administration regulatory requirements. A potency study to assess the vaccine's activity is a crucial regulatory requirement.
This assay must be performed according to some rigorous standards, encompassed in the OECD's good laboratory practice, ensuring that test data are reliable and mutually acceptable globally.
Professor Anna-Lise Williamson is the director of the facility, which her sibling, Associate Professor Carolyn Williamson, helped establish. She was assisted by colleagues Dr Joanne van Harmelen, Dr Katrina Downing, Tracy Blanckensee and Jolanda Truter.
Future studies are planned for the facility, which is available for work to be conducted outside the SAAVI/UCT HIV Vaccine Development Group.
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