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| Introduction |
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| Following the completion of its new headquarters building in 2003, IVI established a Division of Laboratory Sciences dedicated to vaccine research, development, technical assistance and technology transfer. The Division's activities aim to strengthen IVI's overall contribution to vaccine development by working in tandem with the Translational Research Division in molecular epidemiology and laboratory follow-up of vaccine clinical trials. |
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| This Division provides laboratory-based, quality-controlled assays and procedures for typing microbes from field isolates and carries out technology transfer activities to strengthen the capability of IVI-associated field laboratories and vaccine producers in developing countries. Extensive efforts are being devoted to designing novel cost-effective, needle-free, vaccine formulations amenable to large-scale production by vaccine manufacturers from developing countries. Identifying novel adjuvant molecules for enhancing vaccine immunogenicity and reducing vaccine doses constitute another important area of research at the IVI. |
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| The main objectives of the Laboratory Science Division are to: |
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Develop or improve cost-effective vaccine formulations against infections affecting children from developing countries;
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Develop a molecular microbiology platform for detailed characterization of pathogens from field specimens and for selection of candidate strains for downstream vaccine development;
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Develop a clinical immunology platform for monitoring human immune responses to vaccines;
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Identify protective antigens as future components of novel candidate vaccines against selected microbial pathogens;
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Develop novel formulations for improved delivery of vaccines;
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Identify novel adjuvants for enhancing immune responses to vaccines;
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Develop or improve cost-effective processes amenable to large-scale production of vaccines; and
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Provide training and technical assistance in production and quality control procedures to partner vaccine producers, in accordance with international and national regulatory guidelines.
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| In September 2005, Dr. Cecil Czerkinsky joined IVI as Deputy Director General for Laboratory Sciences. The Laboratory Science Division now comprises more than 40 persons, including nine senior scientists with expertise in molecular biology, microbial genetics, bioinformatics, experimental and clinical immunology, vaccine process and quality control, as well as post-doctoral fellows, graduate students and research technicians. |
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| The Division consists of three main departments: |
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| Good laboratory practice (GLP) guidelines have been implemented in all laboratories and a "pre-GMP" (Good Manufacturing Practice) approach is followed in the vaccine process unit. All laboratories have state-of-the-art equipment.
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| IVI's laboratory research and vaccine development activities will expand quite dramatically in the next few years. In addition to the continued development of vaccines against typhoid fever and shigellosis, IVI has embarked on a program to develop vaccines against respiratory infections, such as pandemic influenza, SARS and tuberculosis. Towards that aim, the Division began a recruitment campaign in early 2006 to hire scientists with expertise in molecular virology, respiratory immunology, formulation technologies and clinical laboratory sciences. These scientists will not only strengthen IVI's research and development capabilities, but will also facilitate the integration of experimental research activities both with vaccine process development activities and with clinical and epidemiological research. |
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| IVI is also building a high security containment facility (Bio Safety Level 3+) at its headquarters, which will have combined clinical and animal facilities. This lab will allow the Division to conduct studies on dangerous pathogens, such as pre-pandemic influenza viruses (including highly pathogenic avian influenza virus, e.g H5N1, H7 and H9), coronaviruses (SARS), HIV and Mycobacterium tuberculosis. |
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