Evaluation of a single-platform, rapid, nucleic Acid-based technology for detection of adventitious contaminants of cell culture.

CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA).

Cross comparison of rapid mycoplasma detection platforms.

The use of animal and plant derived raw materials in mammalian cell culture processes may provide a possible route of entry for adventitious contaminants such as mycoplasma. Mycoplasma contaminations of cell culture represent a serious challenge to the production of biotechnology derived therapeutics. The slow growing nature of mycoplasma can disguise their infection of cultures since cells may continue to proliferate, though at reduced levels and with lesser output of engineered protein.

Susceptibility of mouse minute virus to inactivation by heat in two cell culture media types.

Viral contaminations of biopharmaceutical manufacturing cell culture facilities are a significant threat and one for which having a risk mitigation strategy is highly desirable. High temperature, short time (HTST) mammalian cell media treatment may potentially safeguard manufacturing facilities from such contaminations. HTST is thought to inactivate virions by denaturing proteins of the viral capsid, and there is evidence that HTST provides ample virucidal efficacy against nonenveloped or naked viruses such as mouse minute virus (MMV), a parvovirus.

Healthcare reform in New South Wales 1986-1999: using the literature to predict the impact on senior health executives.

While numerous reviews have examined the changing roles, skills, competencies, and educational needs of health service managers as the result of health care reforms, no study has focused specifically on the impact of New South Wales health reforms on the roles, responsibilities and behaviours of senior health executives in the public health sector. This paper briefly illustrates the significant changes in New South Wales health management since 1986. It also examines the forces behind these changes and predicts their impact on NSW Senior Health Executives based on national and international literature, and provides a foundation for further empirical research.

Helping the auto repair industry manage hazardous wastes: an education project in King County, Washington.

From January 1, 2000, to August 31, 2001, a team of environmental health specialists from Public Health-Seattle & King County, a partner in King County's Local Hazardous Waste Management Program, made educational visits to 981 automotive repair shops. The purpose was to give the auto repair industry technical assistance on hazardous waste management without using enforcement action. Through site inspections and interviews, the environmental health staff gathered information on the types and amounts of conditionally exempt small-quantity generator (CESQG) hazardous wastes and how they were handled.