C-SOPS

As we reach our 10th year anniversary and “graduate” from NSF support, C-SOPS is in an excellent position to continue to drive innovation in pharmaceutical manufacturing. As a strong partner both for Industry and for the FDA, C-SOPS is in a unique position to facilitate the integration and implementation of new manufacturing technologies. Strong support from our members, growing partnerships with leading adopters of continuous technology and with the FDA, and a number of new and exciting initiatives are coming together to enable success in the next phase of our center.

 

Moving forward, C-SOPS’ core research program will focus increasingly on continuous manufacturing technologies, emphasizing the key aspects needed to make them reliable, easy to implement, and easy to operate. 

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In addition, in recent months, working directly with companies such as Janssen and government agencies such as the NSF and FDA, we have been able to launch several high-value/high-impact projects. In this mode of engagement, C-SOPS focus on the partner strategic interests and needs, achieving a much deeper level of collaboration. At the present time, several efforts are under way to expand these partnerships and developing new ones. Some of the new project areas are given below:

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• Material Characterization and Processibility for Continuous Tablet Manufacturing

  • Faculties involved: Muzzio/Dave, Cuitino, Drazer, Glasser, Gonzalez, Ierapetritou, Wassgren

  • This theme will address aspects of CM, including design, prediction, and optimization of formulation platforms based on materials property characterization and modification. It includes establishing relationships between key material properties of powder blends and “tabletability” of the blend and means to expand regimes of feasibility for direct compression (DC) as well as dry granulation (DG). Powder agglomeration, sticking and prevention/mitigation thereof will be also addressed with respect to CM platforms (both DC and DG). Expanded database of associated properties, including cohesion, flow, packing density, compactibility, and Drucker-Prager cap properties will be generated and continually updated on pharmaHUB.

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• Process and Unit Operations Modeling

  • Faculties involved: Ierapetritou, Bilgili, Dave, Gonzalez, Ramachandran, Wassgren

  • This theme will be geared towards developing comprehensive process modeling tool-box consisting of unit operations, controller and sensor models together with a material property library, and executive system for assembling and executing integrated process simulations. It involves employing of the reduced order modeling methodologies to be used for flowsheet models, optimization and control. Major unit operations considered include feeders, milling, granulation and hot-melt extrusion based processing, as well as strategies such as staged powder addition in various operations such as mixing and twin-screw granulation.

 

• Processes and Unit Operations for Bioavailability Enhancement

  • Faculties involved: Bilgili, Dave, Muzzio, Ramachandran

  • In this theme, center activities associated with addressing poorly water soluble drugs will be consolidated. Major activities include: (1) HME for amorphous materials, solid dispersions, as well as development of novel nano and micro composite materials through melt or wet granulation techniques, (2) Stripfilm based processing to develop unique products and their characterization. (3) Preparing engineered suspensions that are sterile filterable.

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• Processes Control and Information Management

  • (Ramachandran/Reklaitis,  Ierapetritou, Nagy)

  • This theme integrates various control strategies for all modes of continuous manufacturing of tablets, including direct compression, dry granulation and wet granulation, specifically, twin-screw granulation. Over-arching goal is to move towards a flexible and modular continuous pharmaceutical manufacturing plant that includes real-time sensing and control as well as incorporates various information and knowledge management strategies.

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• Sensor Development and Integration for PAT and RtR

  • Faculties involved: Romanach/Drazer, Cuitino, Gonzalez, Harris, Laird, Mendez, Muzzio, Reklaitis, Santiago

  • In this theme, we address use and integration of traditional PAT techniques such as Near-IR, Raman, particle imagers (e.g., FBRM) as well as development of new sensing systems for process monitoring in continuous manufacturing and real-time-release of products. Novel sensing approaches such as ultrafast transmission NIR, infrared thermography, soft X-ray based on-line mass flow sensing, and microwave sensing for density measurements as well as testing and integration of single particle measurements. The project will use statistical approaches for analysis of data, for example, comparison of dissolution profiles.

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• Methodologies for Improved use of Measured Data

  • Faculties involved: Drazer, Muzzio, Laird, Reklaitis, Romanach