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 webinar, experts will 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. In addition, the experts will explain how these approaches can facilitate in the tech transfer of a program. Lastly, this webinar will feature an overview of Catalent’s oral solid dose turnkey solutions featuring advanced oral solid dosage (OSD) manufacturing technologies and expertise throughout an extensive global network.
Key Learning Objectives:
- Key Considerations for Tech Transfer
- Identification of critical material attributes (CMA), critical process parameter (CPP) and critical quality attributes (CQA) of drug product and how to predict their impact on a formulation and manufacturing processes
- Overview of primary processing technology in OSD manufacturing and how material characteristics dictate the unit operations method.
- Overview of Catalent’s Manufacturing Solutions