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Pharmaceutical Manufacturing and Packing Sourcer

Contract Manufacturing of Biopharmaceuticals: The Regulatory Framework

Currently there is a significant shortfall in biopharmaceutical manufacturing. At present, biopharmaceuticals account for some five per cent of global health care sales. However, it is anticipated that this figure will increase significantly in the coming years. In 2001 biopharmaceuticals comprised around 29 per cent of new FDA approvals. It is estimated that there are approximately 350 biologics in late stage clinical trials and a further 1,000 in late stage development.

The global microbial fermentation capacity may need to double by 2005 and demand would therefore exceed capacity by a factor of four for GMP processing. The total world market size for biopharmaceutical manufacture is likely to grow from $780 million in 1998 to around $1,600 million for 2002. The US currently accounts for 58 per cent of the total market and Europe for 37 per cent.

Currently the requirement for microbial fermentation significantly exceeds that for mammalian cell culture, although it is likely that the cell culture market will grow more rapidly than will microbial fermentation. For many small companies, the use of contract manufacturing facilities is the only available option for producing materials for clinical trials and market.


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By Dr Trevor Marks, Business Manager at the Health Protection Agency, Porton Down

Dr Trevor Marks is currently Business Manager at the Health Protection Agency, Porton Down (previously CAMR). He has been Project Manager for anthrax vaccine manufacture for the past four years.

Trevor joined CAMR in 1979 as a Manufacturing Process Scientist, before moving into research and gaining a PhD in Environmental Microbiology in 1986. Following this, he was active in researching environmental microbiology issues, including bacteriophage-mediated transfer of virulence factors in pathogenic micro-organisms and the use of micro-organisms to degrade environmental pollutants.

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Dr Trevor Marks
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