Vaccine stability study design and analysis to support product licensure.

Stability evaluation supporting vaccine licensure includes studies of bulk intermediates as well as final container product. Long-term and accelerated studies are performed to support shelf life and to determine release limits for the vaccine. Vaccine shelf life is best determined utilizing a formal statistical evaluation outlined in the ICH guidelines, while minimum release is calculated to help assure adequate potency through handling and storage of the vaccine.

Maintenance of vaccine stability through annual stability and comparability studies.

Evaluation of vaccine stability does not end with licensure of the product. An annual stability program helps assure continued quality of product throughout the dating period, while comparability studies are performed after a process or facilities change in order to demonstrate that the change has not impacted the stability characteristics of the product. Careful attention to the design and analysis of post licensure studies helps mitigate the risk of missing a meaningful shift in the degradation rate of a vaccine, as well as the possibility of incorrectly earmarking a stability shift when the product remains acceptable.

Detection of HPV in Norwegian cervical biopsy specimens with type-specific PCR and reverse line blot assays.

Background: Although the association of HPV16 and HPV18 DNA with cervical cancers has been well studied, the prevalence of these types in high-grade cervical intraepithelial neoplasias (CIN2/3) may differ from the prevalence found in cervical cancer specimens.

Objective: To determine the prevalence of specific HPV types found in high-grade CIN2/3 biopsy samples.

Study Design: One thousand eight hundred and forty-eight cervical biopsy specimens were obtained from Norwegian women.

Assessing the reproducibility of an analytical method.

The reproducibility of a validated analytical method may require reassessment because of various reasons, such as the transfer between laboratories or companies, changes in the instruments or software platforms (or both), or changes in critical reagents, among others. This paper is a demonstration of an assay bridging study in evaluating reproducibility. The approach is simple but very informative and offers many advantages over existing approaches.

A novel Staphylococcus aureus vaccine: iron surface determinant B induces rapid antibody responses in rhesus macaques and specific increased survival in a murine S. aureus sepsis model.

Staphylococcus aureus is a major cause of nosocomial infections worldwide, and the rate of resistance to clinically relevant antibiotics, such as methicillin, is increasing; furthermore, there has been an increase in the number of methicillin-resistant S. aureus community-acquired infections. Effective treatment and prevention strategies are urgently needed.

Using QPCR to assign infectious potencies to adenovirus based vaccines and vectors for gene therapy: toward a universal method for the facile quantitation of virus and vector potency.

The assignment of infectious potency to test articles of adenovirus has been conducted mainly using classical end-point dilution methods, which rely on virus induced cytopathology to reveal the presence of infectious virus. These assays suffer the disadvantages of labor intensity, duration, throughput restriction and variability. In the course of our development of an Ad5 based HIV vaccine for clinical evaluation, we sought a facile method for the assignment of potency to the numerous test articles generated during the development of bioprocesses for bulk manufacture, downstream purification and formulation.

Monitoring the stability of human vaccines.

Postmarketing stability studies of vaccines that tend to be close to their clinical specification at the end of the expiration dating period may require enhanced annual monitoring. In addition, an early assessment of product stability prior to completion of each individual study is desired. However, predictive measures of individual lots may produce early indication of failure.