Improving Vaccine Manufacturing Evaluation for Bacterial Respiratory Pathogens

Principal Investigator: Drusilla L. Burns, PhD
Office / Division / Lab: OVRR / DBPAP / LRSP

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Overview

Public Health Issue: Vaccines are an extremely cost-effective public health measure; however they must be consistently manufactured in a manner such that they are safe and effective, requiring, for example, that each lot produced must be the same as the next. In order to assure the quality of vaccines, meaningful tests must be developed, evaluated, validated and conducted at all stages of the manufacturing process, both during the clinical trials used to evaluate the safety and efficacy of the vaccine as well as after licensure.

Regulatory Contribution: Meaningful tests must be designed and evaluated to support the safety, purity and potency of vaccines, by determining the assays that focus on key parameters that will best measure these important parameters.

Research Approach: This research program develops through rational design and evaluates in-process tests, vaccine lot release tests, and clinical studies for anthrax and pertussis vaccines.

Mission Relevance and Outcomes: These studies provide the new scientific tools and knowledge required to support the manufacturing and clinical evaluation of pertussis and anthrax vaccines.

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Publications

J Bacteriol 2008 Nov;190(21):7285-90
Stabilization of the Pertussis Toxin Secretion Apparatus by the C-terminus of PtlD.
Verma A, Cheung AM, Burns DL

Clin Vaccine Immunol 2008 Nov;15(11):1737-41
Role of the N-terminal amino acid of Bacillus anthracis lethal factor in lethal toxin cytotoxicity and its effect on the lethal toxin neutralization assay.
Verma A, Wagner L, Stibitz S, Nguyen N, Guerengomba F, Burns DL

Clin Vaccine Immunol 2008 Jun;15(6):946-53
Interlaboratory Comparison of the Anthrax Lethal Toxin Neutralization Assay used to Assess Functional Antibodies in Multiple Species.
Omland KS, Brys A, Lansky D, Clement K, Lynn F, Participating Laboratories

Infect Immun 2007 May;75(5):2297-306
Requirements for Assembly of PtlH with the Pertussis Toxin Transporter Apparatus of Bordetella pertussis.
Verma A, Burns DL

Infect Immun 2005 Aug;73(8):5222-8
Importance of srtA and srtB for Growth of Bacillus anthracis in Macrophages.
Zink SD, Burns DL

Infect Immun 2004 Sep;72(9):5365-72
Analysis of subassemblies of pertussis toxin subunits in vivo and their interaction with the ptl transport apparatus.
Burns DL, Fiddner S, Cheung AM, Verma A

Infect Immun 2004 Apr;72(4):2057-66
Analysis of relative levels of production of pertussis toxin subunits and Ptl proteins in Bordetella pertussis.
Cheung AM, Farizo KM, Burns DL