Year: 2019-20

Company: Catalent

Liaison(s): Raj Desai, Joseph Pate, William Wessel

Catalent Pharma Solutions is a Contract Development and Manufacturing Organization (CDMO) that provides services to support the biopharmaceutical industry. They are a global leader in the development of biologic drugs as well as manufacturing services; therefore, it is crucial that they remain up to date with the latest technology to address any potential process bottlenecks. With multiple sites across North America and Europe, Catalent strives to utilize the latest technologies to offer the best services in development, analytics, and manufacturing while focusing on quality and efficiency.

The Catalent Team Master’s Project (TMP) is utilizing the Superpro Designer Software to model their batch manufacturing process for monoclonal antibody production as a baseline. The team will expand the simulations to evaluate the potential opportunities for continuous manufacturing processing. The scope of the project entails different scenarios, with three simulations each, involving combinations of fed-batch or perfusion upstream and single column or multi-column downstream. Alongside the simulations, the economics of these scenarios will be assessed using the cost of materials and labor to provide Catalent and its clients a better insight on the benefits and challenges associated with implementing a continuous manufacturing process.

The TMP group maintains regular communication with our corporate liaisons as the simulations are being built to verify the inputs align with Catalent’s current manufacturing process. In addition, the data generated by the model is reviewed with our liaisons to determine the feasibility of implementing a continuous process. Once completed, these models will allow Catalent to further explore the implementation of continuous manufacturing operations in their facilities and offer the option to clients as it increases production, efficiency, and quality.