Executive Briefing Series (formerly The Food & Drug Letter)

Pharma companies’ chief concern with contract manufacturing is managing the risk of cross-contamination in facilities used to produce multiple drug products. It can take only one molecule, in some cases, to ruin an entire batch of drugs. But with ever narrower manufacturing tolerances and more drugmakers turning to contract manufacturing organizations to produce their products, companies need to know they have the right CMO for their job. During a recent FDAnews webinar, Stephanie Wilkins, president of PharmaConsult US, and Kevin Rosenthal, director of manufacturing at Pharmatek, shared their expertise on how best to control cross-contamination in multi-product facilities. This issue of The Food & Drug Letter summarizes their thoughts on the challenges of designing, operating and monitoring shared facilities.

Contract manufacturing organizations (CMO) that produce drugs in shared facilities should base decisions about the risk of cross-contamination on sound science and avoid relying exclusively on risk management tools.

The European Medicines Agency (EMA) plans to develop toxicological guidance for use in identifying the level of risk associated with making different drug products using shared facilities.

Contract manufacturing organizations (CMOs) can reduce the risk of cross-contamination from one drug batch to the next by having a dedicated room to sample parent containers for release and repackage materials for use in production, according to Kevin Rosenthal, director of manufacturing at Pharmatek.

Determining what type of air handling system is needed depends on how the facility will be used. Manufacturers should match the facility’s intent with the appropriate ISO classification, Kevin Rosenthal, manufacturing director at Pharmatek, said (see chart).

Engineering controls are key to an effective cross-contamination prevention plan for multi-product facilities.

Rounding out the integrated approach to cross-contamination prevention is systems and procedures, Kevin Rosenthal, director of manufacturing at contract manufacturing organization (CMO) Pharmatek, said.

Once an integrated cross-contamination prevention program is in place, manufacturers should devise a comprehensive checklist to ensure all facets of the program are meeting specifications.

The FDA issued new guidance in March 2011 to help manufacturers decide when separate buildings are necessary to prevent non-penicillin beta-lactam antibiotics from cross contaminating other pharmaceuticals.

Global revenues for contract pharma manufacturing will exceed $64 billion in 2016, according to London-based business analysis company visiongain.