When a promising drug candidate advances into clinical development, attention is understandably focused on generating the evidence needed to support the next milestone.
However, decisions made about supplying Phase I and Phase II studies can have consequences that extend far beyond those immediate clinical requirements.
Choices regarding formulation, materials, processing and equipment begin to shape how a product can be manufactured at scale.
Manufacturability is therefore a development consideration that should inform early decisions.
A candidate may show encouraging clinical results but then encounter stability or yield issues, prove difficult to scale or require costly redevelopment before it can progress.
It is impossible to remove uncertainty from this process entirely.
Nonetheless, teams can improve their chances of success by bringing the right expertise and information to the table early and designing frameworks that enable them to meet immediate clinical needs without unnecessarily restricting future options.
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