At the ISPE/FDA conference on cGMP’s in Baltimore last week, Andrew Skibo, EVP of operations and manufacturing at MedImmune, spoke on the topic of “High Quality in a Lean Manufacturing World.” The pharmaceutical industry’s increasing focus on reducing manufacturing costs, he said, has come at a time when the industry is also seeing a dramatic increase in quality failures. Biopharmaceuticals, so closely defined by their manufacturing processes and environments, are p
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'On Pharma'