Formulation and CMC planning are essential to turn a promising compound into a clinically usable and manufacturable medicine. The resources in this section cover synthetic chemistry, formulation design and CMC strategy from discovery through preclinical and clinical development, scale-up and manufacture. They also explore how dose, absorption, route of administration and delivery to the site of infection influence product performance and development risk.
Resources
4 resourcesExamines how structural and functional abnormalities in the lung affect the deposition and efficacy of inhaled antibiotics. It draws on computational modelling to challenge the assumption that inhalation reliably delivers high antibiotic concentrations throughout the lungs.
Emphasises that overlooking CMC and formulation strategies can jeopardise project success. Whilst timely, well-planned efforts can enhance success rates, create competitive advantages, and accelerate time to market.
Explores the critical role of CMC in transforming an antibiotic molecule into a safe, effective, and manufacturable medicine suitable for human use.
Discusses fragment-based screening, synthetic chemistry skills required from early discovery to development and how formulation can enhance the properties of a compound.