Catalent Pharma Solutions

Articles by Catalent Pharma Solutions

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 executive summary, 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 executive summary includes 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.

By adapting for each molecule’s unique characteristics and challenges, Catalent uses its expertise and a wide range of tools and technologies to create innovative dose forms that benefit patients.

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In today’s challenging environment, every clinical study is different and changes can occur during project development which require unique, responsive solutions. Catalent offers flexible services designed to keep studies moving.

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