The aim of process development is to establish optimal process parameters and conditions for future large-scale batches or commercialization, ensuring that the product can be successfully manufactured in compliance with required quality and regulatory standards. This ultimately means that an in-depth understanding of the formulation is key.

Unlike solid dosage drug products and sterile injectables, topical and transdermal formulations often contain a higher number of excipients, making them more complex to develop and scale. Given that the processes that can be used for manufacturing a drug product are largely impacted by the specific components of that product’s composition, a strong comprehension of the formulation is key.