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European Biopharmaceutical Review

SMi Conference London March 2003, Biologics: Overcoming the Challenges of Development and Manufacture

The SMi conference was opened by Dr David Glover, Chief Medical Officer at Cambridge Antibody Technology, who outlined the key challenges for biologics manufacture today: the predicted shortage of manufacturing capacity, the decision to outsource or make in-house, and technical and regulatory challenges.

It is predicted that just 10 monoclonal antibody (mabs) products would consume 75 per cent of the worlds' biologic manufacturing capacity and yet there are 60 mabs likely to emerge onto the market in the next one to seven years. However, the estimate of 400 mabs in clinical trial, which is often quoted, is probably an overestimate, as a single mab can be in clinical trial for a number of different clinical indications. This reduces the current estimate from 400 to around 100. Whilst currently, 30 per cent of FDA drug applications are for biotech drugs, a curious statistic is that biologics produced by pharma/biotech alliances have a 70 per cent greater chance of receiving FDA approval. It is not known whether this is a synergistic effort of the companies working together or if biologic drugs are more likely to get FDA approval than chemical entity-based drugs.


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By Keith Chidwick, Consultant at Technomark Consulting Services Ltd
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Keith Chidwick
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