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home > pmps > winter 2003 > manufacturing hazardous biologicals: practical considerations

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Pharmaceutical Manufacturing and Packing Sourcer Manufacturing Hazardous Biologicals: Practical Considerations
Today's pharmaceutical, health care and biotechnology industries face a wide range of technical, commercial and legislative challenges due to modern developments which have served to increase the range of biological products, source micro-organisms and the scope and complexity of accompanying manufacturing operations. Some of these micro-organisms possess the capacity to cause ill health either from infection, allergenic reaction or toxicity. The manufacture of medicines against human and veterinary disease is a prime example of the need to manipulate such microbial pathogens during processing. Although there is an attempt to move to manufacture using recombinant micro-organisms, current licensed processes still depend upon the use of highly pathogenic bacteria and viruses to provide effective vaccines and other therapeutic biologicals. Of particular interest for example is the development and manufacture of vaccines against dual-threat agents such as the anthrax vaccine - the favourite of modern bio-terrorists. Much has been written about the quality and safety requirements of such medicines during their licensure, but particular attention should be made to assessing the hazards and risks to process operator safety during their manufacture. This article describes some of the risks encountered during the manufacture of hazardous biologicals and how modern facility and equipment design can be used to prevent or minimise them to the lowest practicable levels.
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By Dr Howard S Tranter of the Health Protection Agency

Dr Howard S Tranter has worked at the Health Protection Agency (formerly known as CAMR) for over 20 years, working with microbial pathogens and their toxins. His particular area of expertise is the application of GMP and high containment to biological products manufactured from bacterial pathogens. Dr Tranter has previously served as a Biological Weapons Inspector in Iraq for UNSCOM. He has served on the UK Advisory Committee for Dangerous Pathogens and was an Editor for the Journal of Applied Microbiology.