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Thursday, October 28, 2010

Making a Drug Follow-up

Biospace reports a few snafus in the manufacturing side of big pharma.

Sandoz Pharmaceuticals Initiates Voluntary Recall of Ceplene in the US

B. Braun Medical Ltd. Voluntarily Recalls Seven Lots of Heparin Manufactured in 2008 Due to Supplier-Initiated Recall of Heparin Active Pharmaceutical Ingredient (API)

Crucell N.V. (CRXL) Halts Vaccine Shipments to Investigate Plant

This is not a cargo cult issue. It is quite the opposite. The reason for reporting errors and removing drug product from the market could be due to a moral issue of not wanting to hurt anyone or a business decision that makes the potential downside too high of a risk to take. Either way, the best thing to do was to remove the product from the patient.

This adds to yesterdays post on drug discovery vs drug manufacturing. Discovery is riddled with Cargo Cult Science. Manufacturing however must be done in a manner where predictable outcomes are an absolute requirement. When you have a problem you cannot hide it. Discovery is a whole different world.

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