MALARIA VACCINE DEVELOPMENT UNIT (MVDU)

疟疾疫苗和开发股的目标是开发候选疫苗，以便在志愿者和地方病患者中进行测试，并探索下一步的疫苗开发测试思路（管道）。工艺开发将在单位内进行，临床级材料将外包生产。该单位将能够通过在细菌和酵母（毕赤酵母和酵母）中发酵生产重组蛋白，并进行细胞培养;通过可转移用于GMP生产的方法纯化蛋白质;并开发放行质量标准和评估蛋白质功效的测定方法。该公司还将设立一个部门，在非洲长尾猴身上测试重组蛋白的功效，并进行田间试验。目前，有三种产品即将进入测试阶段。两个与恶性疟原虫和间日疟原虫的传播阻断疫苗有关，一个针对MSP 1的C末端。MSP 1疫苗正在以不同的方式生产，并将很快在猴子身上进行测试，为现场试验做准备。- 疟疾疫苗、血液阶段疫苗、传播阻断疫苗-人类受试者

The Malaria Vaccine and Development Unit (MVDU) has as its goal the development of candidate vaccines to the point of testing in volunteers and in endemic people and the exploration of the next ideas for testing for vaccine development (the pipeline). The process development will proceed within the unit, and the clinical grade material will be outsourced for production. The unit will be able to produce recombinant proteins by fermentation in bacteria and yeast (Pichia and Saccharomyces) and do cell culture; purify proteins by methods that will be transferable for GMP production; and develop assays for release specifications and for evaluating the efficacy of proteins. It will also have a unit to do tests of recombinant proteins in Aotus monkeys and in field trials for efficacy.There are now three products that are approaching readiness for testing. Two are related to transmission blocking vaccines for P. falciparum and P. vivax and one is against the C-terminus of MSP1. The MSP1 vaccines are being made in different ways and will soon be tested in monkeys in preparation for field trials. - Malaria vaccine, blood stage vaccines, transmission-blocking vaccine - Human Subjects