Contamination concern rises about CMOs

Managing cross-contamination has increased the most among 19 factors of great importance to drug sponsors as they evaluate contract manufacturers. That's according to consultancy BioPlan Associates' recent analysis and verification of results from a survey it published last spring.

Over the past four years, 32% more biopharma sponsors are seeing CMO cross-contamination-prevention and -handling capabilities as a "very important" factor, writes BioPlan president Eric Langer in PharmaPro.

He's not surprised. "When we started asking this question we thought it would be easier to get information" than it turned out to be, Langer told FiercePharmaManufacturing in a phone interview. "That's where the concern comes from," he said--not knowing how to benchmark one CMO against others for cross-contamination performance.

Langer said the increase may also reflect maturation of the industry and an increased comfort level in the sponsor/contractor relationship. "As the red herring issues fall out--like the issue of contractor location [just two percent now label it 'very important'], the more difficult-to-resolve issues float to the surface," he said in the interview. Cross-contamination has always been a problem. But now, he said, as other issues become less critical, cross-contamination rises in importance.

Another issue retaining its importance to sponsors in their assessment of CMOs is among the most fundamental: the ability to stick to schedule. It saw an increase of 23% since 2008.

Initial survey results appear in the 8th Annual Report and Survey of Biopharmaceutical Manufacturing, published in April 2011. The 500-page report sells for $845.

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