Small Molecule Drug Product Programs with Reduced Complexity

In this interview, Christian Schmitt, VP, Global Commercial Head for CordenPharma’s Non-Sterile Drug Product Business, discusses how integrated development strategies can help innovators overcome common challenges in bringing small molecule drug products from early development into clinical and commercial stages. He explains that many delays arise when development activities are divided among multiple providers, creating additional complexity through process transfers, fragmented documentation, analytical method transfers, and scale-up challenges. By combining drug substance and drug product expertise within a single organization, these risks can be significantly reduced while accelerating development timelines.

Christian highlights the advantages of CordenPharma’s integrated API-to-drug product network, particularly for complex and rapidly evolving therapeutic areas such as oral peptides. He describes a fast-track development approach that combines peptide API manufacturing with early formulation development to quickly generate preclinical samples for evaluating oral bioavailability. Leveraging expertise across both drug substance and drug product disciplines, CordenPharma can help customers assess enabling technologies such as permeation enhancers and hydrophobic ion pairing strategies, providing valuable development insights within a compressed timeframe.

The discussion also explores how CordenPharma supports customers who already have an API and require assistance with drug product development. Christian explains that successful formulation development begins with a thorough understanding of the API itself. Rather than immediately pursuing complex formulation technologies, CordenPharma applies a stepwise, science-based approach, first evaluating the API’s physical and solid-state characteristics before determining the most appropriate development path.

Using the example of a poorly soluble API, he outlines how CordenPharma systematically assesses options ranging from simple capsule formulations to advanced approaches such as multicomponent crystalline forms and amorphous solid dispersions. This structured methodology helps customers avoid unnecessary complexity, reduce development costs, and accelerate timelines by selecting the most efficient solution based on the API’s characteristics. Throughout the interview, Christian emphasizes that the close integration of drug substance and drug product expertise enables smarter decision-making, faster development, and a more streamlined path toward clinical success.