By Alan E. George, ILC Dover
The interest in the use of containment for the development and manufacture of active pharmaceutical ingredients (APIs) including sensitizers by contract manufacturers and contract research organizations is expanding. While stating what may be the obvious to those CMOs and CROs who have been handling these types of potent powders, input from a variety of sources are confirming this growing trend. Publications Notable among publications supporting this conclusion is Contract Pharma Magazine. Several articles have been published here by SafeBridge Consultants and by the magazine’s own editorial staff. In the article “Assessing Potent Compound Safety Capabilities at CMOs”, SafeBridge notes that the CMO’s technical capability to meet clinical or commercial requirements is only one aspect that needs to be evaluated and that there is also a need to ensure, with the same rigor, that these CMOs are capable of safely handling potent APIs and products.
The information provided also addresses some good details on categorizing components by the toxicity and potency as well as systematic steps for determining the control band , setting acceptable exposure levels, the need to measure those same levels, installing the appropriate engineering controls for your process, setting operating procedures, and the need for training. Conferences There have been multiple conferences recently where the growing interest in CMOs looking for training and information that would be useful in their business was evident. Included in this list is the PharmaED Resources conference held in Philadelphia, Pennsylvania in May of this year.