Issue separates bio, small molecule CMOs

The importance of cross-contamination management to drug sponsors seeking to outsource production is greater when the drugs are biologics rather than small molecules. "Because biologics tend to be highly specific in their targeting, they also tend to be highly potent. As such, cross-contamination will always be at the top of the list of concerns," said Tim Scott, president at chemistry-development service provider Pharmatek Laboratories, in a emailed response to a FiercePharmaManufacturing query.

Biologics and small-molecule manufacturing each present unique challenges. Cross-contamination is, of course, an issue in all drug manufacturing, Scott explained. But it should be a given in CMO selection for small molecules. "If a sponsor has a question about cross-contamination, [the sponsor] should not be working with that vendor," Scott wrote. "That is a quality issue that goes directly to the core of [GMP production]. Why would you hire a 'GMP manufacturer' that can't manufacture by GMP?"

The query was prompted by consultancy BioPlan Associates' recent finding that managing cross-contamination had increased the most among 19 factors of great importance to drug sponsors as they evaluate contract manufacturers. The concern stems from not knowing how to benchmark one CMO against others in terms of cross-contamination performance, said BioPlan president Eric Langer.

Langer said also the enhanced concern might reflect an increased comfort level in the sponsor-contractor relationship for bioprocessing. As other issues have become more routine and less of a concern to sponsors, those that remain--typically the more difficult ones--appear to grow in importance.

Pharmatek's Scott noted another reason for the increased comfort level between bio sponsors and contractors. Layoffs and acquisitions over the last three years have shrunk the industry. There are fewer pharma companies, with the weaker ones failing. Fewer CMOs remain because those that couldn't survive the economic downturn went out of business, according to Scott. "This left a smaller group of strong CMOs that provide better service, and a smaller group of pharma companies that manage their business better and know the importance of managing relationships," he wrote.