Company: Catalent Pharma Solutions
Liaison(s): Pamela Barton, Scott Biedron, Morgan Gilles, Victor Vinci, Emily Schirmer
Catalent Pharma Solutions is one of the world’s largest contract development and manufacturing organization (CDMO) companies, providing integrated technological solutions for the industry. This allows for Catalent’s clients to use pre-existing facilities and technology to generate product material, allowing clients to save both time and money while focusing on drug discovery and marketing. Catalent’s success is attributed to a strong diversification approach which has allowed them to build a robust intellectual property pipeline.
Prior to this project, the Madison, Wisconsin site had individual departments manually collecting trending data, resulting in process trending and analysis inefficiencies. The KGI Team is working on developing and/or selecting a centralized process information management system that will trend upstream and downstream manufacturing processes on a periodic basis. This data will be used to create reports and visualizations that will allow the Catalent technical team to more efficiently identify potential process risks and optimization opportunities during daily review. This process information management system will also be used by the Catalent technical team to confirm process performance qualification (PPQ) readiness by evaluating product quality attribute data, process parameter data, step yields, processing times, and bioburden and endotoxin data.
This centralized process information management system will also be a powerful tool for showcasing and informing clients of the process data throughout a product’s manufacturing lifecycle. The dashboards containing the reports and data visualizations will be designed with ease of customization in mind to meet specific client needs, ultimately helping further enhance Catalent’s already strong client relationships.