|Project Title||Production, Purification and Immunogenicity of a Malaria Transmission-Blocking Vaccine Candidate: TBV25H expressed in Saccharomyces cerevisiae|
|Project Type||Contained Use (Laboratory)|
|Name of Institution||National Institute of Molecular Biology and Biotechnology (BIOTECH),University of the Philippines Los Banos, College, Laguna,049-536-2721; 536-2724|
|Cooperating Institution||National Institutes of Health|
|Project Leader(s)||Fidel Rey P. Nayve|
|Experimental Facility/Site||Philippines (Biotech- UPLB)|
|Purpose / Objectives||1. To establish yeast fermentation, protein purification and vaccine formulation capabilities for producing research- grade recombinant subunit vaccines in the Philippines.
2. To establish procedures for manufacturing yeast- derived recombinant subunit vaccines under Good Manufacturing Guidelines in the Philippines.
3. To produce a malaria transmission- blocking vaccine suitable for use in human clinical trials in the Philippines.
|Biosafety measures||All persons involved in the experiment will be oriented on the proper handling and decontamination procedure that will be enforced and BL1 and BL1-LS level containment will be observed.|
|Conditions for Approval||N/A|
|Date of Approval||1994-07-25|
|Regulated Materials||-plasmid: pTBV25HU and yeast: 2905/6 strain|
|Subject||Request of Fidel Rey P. Nayve Jr for permit to import plasmid: pTBV25HU and yeast: 2905/6 strain|
|Requesting Party||Dr. Francisco Zapata, Tissue Culture Specialist|
|Action of NCBP||Approved for implementation
For issuance of permit to import plasmid: pTBV25HU and yeast: 2905/6 strain by the Plant Quarantine Services, Bureau of Plant Industry