A very interesting article by Sarah Houlton appeared in Chemistry World this week that looks at how the withdrawal of drugs from the market and manufacturing failures have served to highlight the need for the pharma industry to ensure that the medicines supplied to consumers only contain what they should.
Featured in the article are Chris Oldenhof, who works in external regulatory affairs at Dutch chemicals producer DSM, Guy Villax, chief executive of Portuguese manufacturer Hovione, and Bruce Lehr, Director of Development at SAFC. Lehr talks about how Pharma companies are seeking greater information from suppliers, including greater levels of characterization around raw materials. Building on this theme, SAFC has set up its own enhanced raw material characterization program for cell culture media sold to biopharma manufacturers. Lehr goes on to talk about the steps that SAFC has taken to monitor and deal with any variance in composition of materials and the need for due diligence throughout the supply chain. and how putting that in place can ensure all materials meet all specifications.
You can read the article in full here:
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