The use of contract development manufacturing organisations (CDMOs) is now the established norm in the pharma/medtech supply chain. The CDMO model provides cost-effective, reliable and compliant solutions with speed to market for critical healthcare products. It takes advantage of core competencies/experience from the contract giver (eg, brand development, marketing, etc) and contract acceptor (eg, manufacturing excellence, quality operations, etc) to allow for targeted focus on key operational pillars to ensure overall programme success and synergies.
However, with a multitude of 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, having to juggle between the technical non-negotiables and setting the foundations to deliver on a common and cohesive product goal.
Here are some considerations prior to engaging with a potential CDMO:
- Have a clear understanding of your project status and objectives
- What exact capabilities are required from a CDMO (understanding the ‘essentials’ vs ‘nice to haves’)
- What phase is your project at and what are the current timelines?
- What are the known current risks, eg component supply, method validation, regulatory approval, etc
- Have mitigation actions been identified and accessed?
- What is your commercial forecast and ‘go to market’ strategy?
- What funding is available and is funding available to accelerate the timeline if needed?
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