Challenges in API Technical Transfer

For contract development and manufacturing organizations (CDMOs) looking to scale-up processes throughout development phases and through to commercial scale, tech transferring of projects is a necessary skill. This may be an internal transfer from a development site or pilot plant to another facility, or taking on a new project from a customer site where the previous work has been undertaken by the customer or a third party. Either scenario has many challenges, which may bring about unforeseen consequences of scale-up, but to ensure a successful transfer to production sites, key process risks and analytical parameters must be identified to ensure that all critical information has been successfully incorporated.

External Transfers

A chemical process that a CDMO has never previously undertaken must be fully evaluated, based on the information shared by the customer before a CDMO bids on the project. The key areas that must be assessed are safety, the process needs in terms of the chemistry, and the analytical technical package.

Even with limited information, it is highly unusual for any chemistry development to be trialed prior to quoting on the pro