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home > pmps > spring 2003 > good development manufacturing contributes to drug development success
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Pharmaceutical Manufacturing and Packing Sourcer

Good Development Manufacturing Contributes to Drug Development Success

The process of drug development cannot proceed without a supply of drug substance (DS) to supply both preclinical and clinical testing. Development manufacturing (DM) is the term used to describe the development of processes and analytical controls for the manufacture of the drug substance, preclinical test articles (TA), and drug product (DP) for supply to preclinical and clinical studies. It forms the basis of the manufacturing section of a marketing authorisation application (MAA).

Outsourcing in the clinical and preclinical areas is well established, but outsourcing of development activities related to manufacturing is a more recent phenomenon. DM outsourcing has proceeded more slowly than in other areas. Reasons for this are complex, including the high cost of setting up a DM facility, and a strong desire amongst research-based companies to retain all information about manufacturing processes in-house.

However, over recent years a comprehensive service to the development phase of manufacturing has developed - driven by demand from both small companies unable to set up their own facilities, and from major pharmaceutical companies unable to meet demand within the organisation, or looking to reduce costs. If the hoped-for flood of new compounds into development, generated by the new techniques in research and application of genomics for example, actually materialises, outsourced development manufacturing will have to become more widespread.


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By Michael Gamlen, Managing Director of Pharmaceutical Development Services Ltd

Michael Gamlen is currently Managing Director of Pharmaceutical Development Services Ltd, a consultancy based in Guildford, UK. Michael was Head of Tablet Development at the Wellcome Foundation Ltd for 15 years, before joining Vanguard Medica in 1996.

He started Pharmaceutical Development Services Ltd in 2000. He has been responsible for the pharmaceutical aspects of at least seven drugs currently on the market and has over 25 years' experience in the industry.

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Michael Gamlen
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