Strategies For Optimal Scale-Up And Technology Transfer Of Oral Small Molecules

The transition from early phase to late phase of a small molecule program plays a pivotal role in determining a program’s ultimate success. Early planning strategies can help minimize the burdens often faced in that transition.

The implementation of modeling tools to analyze the relationships between material attributes, process parameters and product performance can provide an enhanced understanding of the drug product and improve manufacturing efficiency. In this white paper, experts demonstrate how Catalent’s (multivariate) modeling tools can help understand the relationship between material Critical Material Attributes (CMAs), unit operation Critical Process Parameters (CPPs), and their impact on the finished dosage. Experts also explain how these approaches can facilitate the tech transfer of a program.

Learn more about identification of CMAs, CPPs, and CQAs of drug products and how to predict their impact on a formulation and manufacturing processes, as well as the primary processing technology in OSD manufacturing and how material characteristics dictate the unit operations method.