505(b)(2) Expertise In CMC
In general, CMC considerations and information are agnostic to the type of drug product and development program. However, some CMC factors become especially important for 505(b)(2) applications. Drug Substance related factors include polymorphism, enantiomerism, isotope labeling (e.g. deuteration), salt form and use of prodrug derivatives (e.g. esters). Drug Product related factors include dosage form, route of administration, fixed dose combinations, and drug-device combinations. These factors can all affect the quality attributes of the product responsible for the product’s identity, purity, potency, quality and stability. The more these factors in a developmental drug differ from that of the listed or reference drug, the more significant their effect on the product quality attributes. The differences also pose a challenge for demonstrating the robustness and reproducibility of the product’s manufacture. Ultimately, it is crucial to ensure that the content and timing of the CMC program matches the accelerated requirements of the overall drug program.
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