Use of Contract Development Manufacturing Organisations (CDMOs) is now the established norm in the pharmaceutical and medical technology supply chain. 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 programme success and synergies. However, with many CDMO options available, all providing specialised 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) by the US Food and Drug Administration and the European Medicines Agency (EMA). The FDA sets out the minimum cGMP to assure that safety requirements are adhered to across the lifecycle of a drug and that it “Meets the quality and purity characteristics that it purports or is represented to possess.”
Beyond these critical requirements, there are several key considerations we recommend before engaging a potential CDMO.
Understand the Project Status and Objectives
Make sure you understand the exact capabilities that you require from a CDMO, including both the essentials and the nice-to-haves. This will vary, depending on what phase your project is at and the current timelines. Be clear about the known current risks that may impact on project timelines, such as raw material supply, testing queues if using external laboratories, regulatory approval, etc. Have mitigation actions for each of these risks been identified and assessed? Consider your forecast and strategy for when you expect to go to market. What funding is available and is this sufficient to accelerate the timeline if needed?
Research the CDMOs Identified
Next, do some basic research to differentiate between the selected CDMOs. Key factors to consider as part of your criteria for the selection of a CDMO include technical knowhow and other key skill sets, quality and compliance, and approach to risk.
Technical Knowledge and Experience
Consider how long the CDMO has been in operation and if they have a proven track record in your niche technology. Review their case studies, success stories, and client reviews. Balance technical know-how with ability to deliver a quality product on time and within budget. That will mean weighing cost, speed, and quality in your decision-making. Sometimes speed incurs an additional upfront cost but can pay significant dividends in the long term with gaining market share. Ask whether the CDMO can support your forecast commercial ramp-up plans. Do they have the expertise in technology transfer and ability to scale-up? And can they offer an end-to-end finished product solution – from packaging to distribution to post-market surveillance?
