Biosafety & biosecurity

In some aspects of our research and development, we need to work with biohazardous, or potentially biohazardous materials. We have strict standards and procedures in place to manage the risk wherever biohazardous materials are handled. 

Our biosafety1 risks are associated mainly with four different types of activities; those involving human or animal blood and tissue samples where the risk is associated with infectious agents that may be present; work with naturally occurring pathogens; with several toxins of biological origin; and with genetically modified micro-organisms, the vast majority of which pose negligible risk to human health.

There is an internationally recognised four-category hazard classification system for pathogens, where Category 4 represents the greatest hazard. The assigned hazard category is based on the severity of the disease caused, the way the disease is transmitted, and the availability of effective preventive and therapeutic measures (such as vaccines and antibiotics). In terms of risks to human health, we carry out no work involving Category 4 but we do work with tuberculosis bacilli and are planning work that involves viruses classified in Category 3. We also use a number of Category 2 pathogens at some of our sites.

Backed by our Global Biosafety Guideline, standards and operational procedures, we have programmes in place wherever biohazardous materials are handled, to manage the risk. Measures include staff training, control of exposure at source and where appropriate, provision of personal protective equipment and immunisation programmes.

Specific legislation has been enacted in the US and UK to protect against the deliberate misuse of certain pathogens and biological toxins which have the potential to be used in terrorist activity. AstraZeneca fully complies with the security measures required by this legislation, and we are also developing an AstraZeneca Global Biosecurity Procedure that will require appropriate security to be in place for all relevant materials, whether or not there is a specific legal requirement.

AstraZeneca has been active in supporting a number of external activities addressing biosafety and biosecurity. In 2008 these included representation on the UK Health and Safety Commission’s Scientific Advisory Committee on Genetic Modification (SACGM), and on a Working Group of the UK Advisory Committee for Dangerous Pathogens, which is charged with developing a common set of containment standards to be applied under the Government’s proposals to develop a single regulatory framework for human and animal pathogens. AstraZeneca also participated this year in an industry panel discussion at the Biological Weapons Convention Meeting of Experts in Geneva in August, and at an International Roundtable on Sustaining Progress in the Life Sciences: Strategies for Managing Dual Use Life Sciences Research, co-sponsored by the United States Government and the World Health Organization.

1 “Biosafety” is used to describe the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to biological agents and toxins, or their accidental release while “Biosecurity” is used to describe measures for access control and accountability for use of biological agents and toxins within laboratories, in order to prevent their loss, theft, misuse, diversion of, unauthorised access or intentional unauthorised release.

The content of this page was externally assured by Bureau Veritas, February 2009.