Francisco Manuel Reyes Sosa, head of business development at 53Biologics, explores why biotech companies need flexible CDMOs for early-stage biologics.
For an early-stage biotech company, the route from a promising biologic candidate to clinical supply rarely follows the plan drawn up at the outset. New analytical data can change development priorities, unexpected process results may require additional work and funding or clinical milestones can alter timelines at short notice.
However, development and manufacturing models are often built around relatively fixed schedules and scopes. While this structure provides control, excessive rigidity can become a constraint when the program itself is still evolving.
For biotech companies operating with limited resources and pressure to reach value-creating milestones quickly, flexibility must be considered alongside technical capability when selecting a contract development and manufacturing organisation (CDMO) partner.
