The task of identifying the contract manufacturing organization (CMO)is beyond the scope of this article. Information about CMO selection may be available through networking with pharmaceutical colleagues or in trade journals (1–5).
Confidentiality agreementOnce a contract facility is identified, a confidentiality agreement, also known as a nondisclosure agreement, is prepared by the sponsor's or the contractor's legal department before any exchange of information. When the confidentiality agreement is written by the sponsor, the agreement is forwarded to the contractor's legal department for review. If both companies differ on the content of the agreement, they negotiate the terms until a signed agreement is executed. The confidentiality agreement may be written by the contractor when the sponsor does not have a department that writes confidentiality agreements (e.g., a small start-up company).
The agreement must be a bilateral confidential disclosure agreement. This type of agreement provides for the sharing of information on a confidential basis between both companies. Both parties agree not to disclose the other's proprietary information to any third parties other than affiliated companies and consultancy firms that are bound to the terms of the confidentiality agreement.
The confidentiality agreement is approved and signed by senior management at both companies. Confirmation of an executed confidentiality agreement by the clinical manufacturing representative is important before exchanging information about the active pharmaceutical ingredient (API), drug product, and manufacturing operation and performing a CGMP audit with the contractor.
After the confidentiality agreement is signed, a technical assessment of the contract facility is recommended. The technical assessment can be performed by the clinical manufacturing representative and the formulator.
Of course, the most important aspect is to get a feeling for the type of working relationship the sponsor and the contractor will have (6). A good working relationship is especially important when the sponsor's long-term goal is to commercially manufacture the new drug product at the contract facility. This project involves the two companies working together through manufacturing clinical supplies, registration batches, technology transfer, process validation (7), and the US Food and Drug Administration preapproval inspection (8).