Production , purification and preparation of various candidiate vaccines

该股继续致力于开发针对福氏志贺氏菌和炭疽杆菌的新疫苗，产品目前正在进行临床试验。建立了重组铜绿假单胞菌外毒素A的生产和纯化方法，并制备了克量的蛋白。通过将该蛋白质与细菌多糖缀合，将该蛋白质用于制备缀合疫苗。建立了一种从炭疽杆菌中获得灭活保护性抗原的生产和纯化方法，并制备了克量的这种蛋白。这种炭疽疫苗正在使用几种不同的配方进行研究：甲醛处理，甲醛处理与明矾，明矾单独和未经处理的蛋白质。此外，目前正在准备将保护性抗原与炭疽荚膜结合用于临床研究。制备了几种蛋白质用于评估作为缀合的潜在候选物，其中包括艰难梭菌的重组毒素A和重组白喉类毒素。 生物技术股还与国家免疫发展研究所疟疾疫苗开发股合作，从巴斯德毕赤酵母中生产了大量实验性重组疟疾传播阻断疫苗。该股还参与改进质粒DNA的生产程序，评价不同的宿主微生物。通过替换现有的E.大肠杆菌生产菌株与遗传修饰的菌株。

The Unit continued work on the development of new vaccines against Shigella flexneri and Bacillus anthracis, products are currently in clinical trials. A production and purification procedures for recombinant Pseudomonas aeruginosa exotoxin A was developed and gram quantities of the protein were made. This protein was used for the preparation of a conjugated vaccine by conjugating the protein to the bacterial polysaccharide. A production and purification procedure for obtaining inactivated protective antigen from Bacillus anthracis was established and gram quantities of this protein were made. This anthrax vaccine is being studied by using several different formulations: formaldehyde treated, formaldehyde treated with alum, alum alone, and untreated protein. Additionally, conjugating the protective antigen with the anthrax capsule is currently being prepared for clinical studies. Several proteins were prepared for evaluation as a potential candidate for conjugation, among them recombinant toxin A of Clostridium difficle and recombinant diphtheria toxoid. The Biotechnology Unit also produced large quantities of experimental recombinant malaria transmission blocking vaccine from Pichia pastoris, this work was done in collaboration with the Malaria Vaccine Development Unit of NIAID. The Unit was also involved in improving the production procedure of plasmid DNA, evaluating different host microorganisms. Significant increase in specific production was achieved by replacing the current E. coli production strain with a genetically modified strain.