Developing and manufacturing attenuated live bacterial vaccines

BioPharm International

Volumn 21, Issue 10 SUPPL., 2008, Pages 6-14

  Dietrich, Guido ^a   Collioud, Andre ^b   Rothen, Simon A ^c  

^a GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^b Berna Biotech AG   (Switzerland)

^c Sartec GmbH   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIAL VACCINE; BCG VACCINE; CHOLERA VACCINE; LIVE VACCINE; PLACEBO; TYPHOID VACCINE;

ABSENCE OF SIDE EFFECTS; ARTICLE; BACTERIAL STRAIN; CHOLERA; CLINICAL TRIAL; DISEASE MODEL; DRUG EFFICACY; DRUG EXCRETION; DRUG FEVER; DRUG FORMULATION; DRUG MANUFACTURE; DRUG OVERDOSE; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; GASTROINTESTINAL SYMPTOM; GENETIC STABILITY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IN VITRO STUDY; IN VIVO STUDY; INFECTION PREVENTION; LICENSING; MONITORING; MYCOBACTERIUM BOVIS; NONHUMAN; QUALITY CONTROL; RISK ASSESSMENT; SALMONELLA TYPHI; TUBERCULOSIS; TYPHOID FEVER; VIBRIO CHOLERAE; VIRUS STRAIN;

EID: 56249116655     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (17)

1. Sonnleitner B, Locher G, Fiechter A. Automatic bioprocess control. 1. A general concept. J Biotechnol. 1991;19 1-18.
2. Locher G, Sonnleitner B, Fiechter A. Automatic bioprocess control. 2. Implementation and practical experiences. J Biotechnol. 1991;19:127-144.
3. Rothen S A, Saner M, S Meenakshisundaram, Sonnleitner B, Fiechter A. Glucose uptake kinetics of Saccharomyces cerevisiae monitored with a newly developed FIA. J Biotechnol. 1996;50:1-12.
4. Calmette A, Guerin C, Negre L, Bocquet A. Sur la vaccination préventive des enfants nouveau-nés contre la tuberculose par le BCG. Ann Inst Pasteur. 1927;3:201.
5. Levine MM, Farreccio C, Black RE, Germanier R. Large-scale field trial of Ty21a live oral typhoid vaccine in enteric-coated capsule formulation. Lancet. 1987;1:1049-1052.
6. Levine MM and Kaper JB. Live oral vaccines against cholera: an update. Vaccine. 1993;11:207-212.
7. Behr MA, Wilson MA, Gill WP, Salamon H, Schoolnik GK, Rane S, Small PM. Comparative genomics of BCG vaccines by whole-genome DNA microarray. Science. 1999;284:1520-1523.
8. Germanier R, Fürer E. Isolation and characterisation of Gal E mutant Ty21a of Salmonella typhi: a candidate strain for a live, oral typhoid vaccine. J Infect Dis. 1975;131:553-558.
9. Pasetti MF, Levine MM, Sztein MB. Animal models paving the way for clinical trials of attenuated Salmonella enterica serovar Typhi live oral vaccines and live vectors. Vaccine. 2003;21:401-418.
10. Tacket CO, Cohen MB, Wasserman SS, et al. Randomized, double-blind, placebo-controlled, multicentered trial of the efficacy of a single dose of live oral cholera vaccine CVD 103-HgR in preventing cholera following challenge with Vibrio cholerae 01 El tor inaba three months after vaccination. Infect Immun. 1999;67:6341-6345.
11. Viret JF, Dietrich G, Favre D. Genetic aspects relevant to the biosafety of the recombinant live oral Vibrio cholerae strain CVD 103-HgR. Vaccine. 2004;22:2457-2469.
12. Bloom BR, Murray CJL. Tuberculosis: commentary on a reemergent killer. Science. 1992;257:1055-1064.
13. Dietrich G, Mollenkopf HJ, Weber H, Diehl KD, Knapp B, Kaufmann SHE, Hundt E. Cultivation of Mycobacterium bovis BCG in bioreactors. J Biotechnol. 2002;96:259-270.
14. Dietrich G, Griot-Wenk M, Metcalfe IC, Lang AB, Viret JF. Experience with registered mucosal vaccines. Vaccine. 2003;21:678-83.
15. Pharmaceutical Inspection Convention. Guide to good manufacturing practice for medicinal products. Annex 2 manufacture of biological medicinal products for human use. Available from: http://www.picscheme.org.
16. Monograph: Typhoid Vaccine (Live, Oral, Strain Ty21a). European Pharmacopiea 5.0/1055
17. Monograph: BCG Vaccine (lyophilized). European Pharmacoplea 5.0/0163.