Preparing For Your CDMO Selection Process

The number of biologics in development continue to increase at a rate and contract development and manufacturing organizations (CDMOs) are responding to this rapid rise in business. With this growing market breeding new competition each year, the CDMO outsourcing options available to drug sponsors can be overwhelming. Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Some companies, especially those with limited experience in the biopharmaceutical industry, may find themselves unprepared when it comes to beginning the search.

Without careful consideration of what are the most important features you need from a CDMO and preparing for what the CDMO needs from you, the result can be a mismatch between the CDMO’s core competencies and the sponsor’s expectations. In the case of technology transfer of an R&D or GMP manufacturing process, if insufficient information is provided on the processes required for manufacturing or the anticipated scale, the CDMO will have difficulty assessing the scope of the project. This can ultimately affect their ability to give accurate timelines and contract information. When the sponsor gathers specific information before contacting the CDMO, it allows for a more productive and accurate technical discussion between the CDMO and sponsor and increases the success rate of the program.