Contract Development and Manufacturing Organization Best Practices

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Outsourcing research and development services and manufacturing has historically been an “either/or” choice for pharmaceutical companies looking for efficiencies, expertise and cost savings. But, recent operational shifts in the industry have created new, comprehensive approaches to R&D and manufacturing that have enabled start‐up and big pharma companies to recognize benefits inherent in partnering with a single‐source provider.

Industry reports identify a growing competitive landscape internationally, which has created a greater demand for outsourced services; but how does one find a contract development and manufacturing organization (CDMO) with the appropriate capabilities, expertise, readiness and proven ability to transition from concept to commercialization?

Key elements in choosing a CDMO should include:

  1. Regulatory Compliance Record – A stellar compliance record demonstrates the company’s knowledge and understanding of the approval process.
  2. Size and Critical Mass – A CDMO must have the in-house workforce and technology to meet client needs on time and on budget.
  3. Expertise and Track Record – Proven expertise in relevant dose forms and successful history of developing and commercializing products.
  4. Interpersonal Chemistry – With a focus on team chemistry rather than the science of chemistry, the CDMO team assigned to a client must work together to support the project and ensure a successful transition.
  5. Financial and Strategic Stability – A CDMO must have the financial, strategic, and management stability to remain dedicated to its contract customers and service provider model today and many years down the road.