Enabling a sustainable and mutually beneficial CDMO partnership
ANNETTE BOLAND
Quality & Compliance Executive at PharmaLex, a Cencora Company
Abstract
The role of Contract Development Manufacturing Organizations (CDMOs) in the pharmaceutical and medical technology sectors is evolving, becoming essential for cost-effective and compliant solutions. Key considerations for selecting a CDMO include adherence to current Good Manufacturing Practice (cGMP) regulations and a clear understanding of project objectives. Companies need to conduct thorough research on CDMOs’ technical capabilities, quality management systems, and risk attitudes. Additionally, the focus needs to be on building a strong partnership based on transparency and communication, ensuring that the CDMO is integrated as an extension of the business to achieve shared goals in patient safety and quality.
Use of Contract Development Manufacturing Organizations (CDMOs) is now the established norm in the pharmaceutical and medical technology supply chain (1). The CDMO model has been shown to provide cost-effective, reliable and compliant solutions with speed to market for critical healthcare products.
This is achieved by leveraging the core competencies and experience of the contract giver (e.g. brand development, marketing, etc.) and contract acceptor (e.g. manufacturing excellence, quality operations, etc.) to allow for targeted focus on key operational pillars to drive overall program success and synergies (2).
However, with many CDMO options available, all providing specialized expertise and solutions for diverse and complex activities, it can be difficult to know where to start with the selection process in a way that balances the fundamentals and aspirational goals.
Starting with the non-negotiables, companies must make sure that any partnership adheres to requirements laid out in current Good Manufacturing Practice regulations (cGMP) (3) by the US Food and Drug Administration and the European ...
