Pitfalls of a Non-Integrated Drug Development Process

When your company decides to explore options to develop your drug product, there are endless possibilities. However, this excitement is often quickly followed by a daunting list of possible avenues to go from clinical to commercial.

The vision that allowed you to get this far has been realized, but now you face an entirely new challenge. You must decide between an integrated or a non-integrated drug development approach, determining whether to use multiple vendors for the API, solid state development on API, drug product and analytical services. Which approach will be the fastest, most cost-effective and ulitmaley reduce risk? With each choice, you must be weigh your priorities and adjust your risk tolerance.

Utilizing the strengths of different vendors is a classic approach to supply chain management to reduce risk through diversification. However, timelines frequently lengthen due to handoffs between service providers. In clinical development, time is money. Without a fully-integrated contract development and manufacturing organization (CDMO) overseeing the project, the process becomes more and more fragmented and critical milestones are impeded.

Increased Risk of Supply Chain Complexity

Non-integrated services also translate to a complex supply chain. Risks are amplified when an early formulation decision is made, impacting multiple vendors without direct feedback from the upstream processes. This leads to complications in developing a targeted API process that supports the final dosage form and the quality attributes that ensure its repeatability and scalability. With teams not aligned, they are prone to re-development with the potential to need to repeat a clinical phase study. Additionally, if the early development CDMO is not capable of supporting commercial volumes, tech transfers may suffer inconsistencies with raw materials and manufacturing equipment which complicates the process.

Instead of one development support team looking at the process as a whole, non-unified teams from different companies can only assess and regulate risk at their stage of the process, but not the entirety of the process. Ultimately, a disjointed drug development strategy can lead to a more complex, and riskier path. The integrated services of an end-to-end supply chain affords a faster, safer alternative to classically diversified supply chain management.

Learn more by registering for Alcami's on-demand webinar titled, "Critical Drug Substance Considerations for Formulation Success in Drug Product Development." 

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