Although this personalised approach has enormous clinical potential, it also introduces challenges during formulation, delivery and manufacturing that traditional development models cannot handle.
Many emerging compounds possess poor solubility, unpredictable pharmacokinetics or stability concerns that render them incompatible with conventional dosage forms.
Meanwhile, the need to improve patient adherence with more tolerable delivery routes or reduced pill burden adds a second layer of complexity.
These dual pressures are redefining what is required from contract development and manufacturing organisations (CDMOs).
In today’s landscape, agility, creativity and scientific integration are no longer desirable traits: they are essential.
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