C-SOPS, Thermo Fisher Scientific to accelerate research on continuous manufacturing techniques for drug discovery

The Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), based at the Rutgers School of Engineering, and Thermo Fisher Scientific have collaborated to accelerate the university's ongoing research on continuous manufacturing techniques for pharmaceutical discovery.

With support from Thermo Fisher Scientific, C-SOPS has obtained the Pharma 11 twin screw extruder/granulator, which will be used for testing of hot melt extrusion (HME) and wet granulation processes in continuous manufacturing. The equipment will be housed at the center's full production-scale continuous direct compression solid oral dosage manufacturing facilities.

"We are very pleased to deepen this important relationship with Thermo Fisher Scientific," said Fernando J. Muzzio, director, National Science Foundation/Engineering Research Center on Structured Organic Particulate Systems and distinguished professor at Rutgers. "We look forward to working with other industrial partners on their particular applications and welcome them to join us."

Researchers at C-SOPS will focus on developing polymer selection criteria for HME tamper resistant and sustained release formulation science. They also will explore twin screw granulation formulation science with an emphasis on understanding binder time scales because those from batch applications are often not relevant.

The Rutgers Engineering Research Center, established nine years ago with funding from the National Science Foundation and a consortium of more than 40 companies within the pharmaceutical sector, is the world's largest academic-based research organization dedicated to modernizing pharmaceutical manufacturing of solid oral dose medications.

C-SOPS engineers designed and built one of the first full production-scale continuous direct compression solid oral dosage manufacturing facilities, which is being used as a model by pharmaceutical manufacturers. This direct compression tableting line, located at the Rutgers School of Engineering in Piscataway, has been expanded to include wet and dry granulated production capabilities and can accommodate tests of multiple production routes under automated control for optimal product and process design.

Continuous manufacturing offers a number of significant benefits and is expected to replace conventional batch processing for many products. The pharmaceutical industry has been slow to adopt this technology, which is the standard in many other industries. However, in recent years the pace has accelerated following increased support from the U.S. Food and Drug Administration (FDA) for these processes.

"As the FDA encourages drug manufacturers to consider adoption of new continuous manufacturing technology, we see collaborations like this playing a vital role in the pharmaceutical industry's evolution," said Phillip van de Werken, vice president/general manager, molecular spectroscopy for Thermo Fisher Scientific. "Our collaboration with C-SOPS will help in the development of improved drug delivery systems and manufacturing processes. We look forward to working closely with the Rutgers Engineering Research Center."

Since the center's founding, researchers at Rutgers have worked in collaboration with industry and its partner universities—Purdue, the New Jersey Institute of Technology and the University of Puerto Rico—to develop an understanding of the science that goes into designing and operating continuous pharmaceutical manufacturing systems for solid oral dosage forms.

C-SOPS has been researching a wide variety of areas, including powder processing and materials properties, process modeling and control, and in-line process analytical technology in order to design and implement robust and reliable manufacturing processes that meet the quality standards of a regulated industry at lower cost.

"Continuous manufacturing represents the future of advanced pharmaceutical manufacturing and will produce significant improvements in efficiency, safety, cost and speed to market," Muzzio said. "Our ability to partner with leading companies continues to position the center to best serve the scientific community, the pharmaceutical industry and the regulatory agencies."