Founded in 2006, the Center for Structured Organic Particulate Systems (C-SOPS) brings together leading researchers from major universities to work closely with industry leaders and the USFDA in order to develop the science and engineering methods for designing, scaling, optimizing and controlling dosage forms and relevant manufacturing processes.
C-SOPS is committed to modernizing pharmaceutical manufacturing by developing a scientific foundation for the optimal design of structured organic particulate systems (i.e., active pharmaceutical ingredients (API) dispersed in an organic matrix) as well as actively applying the concepts of Quality by Design (QbD), an FDA initiative that has broad implications to overhaul the approach that pharmaceutical manufacturers use in facility design and operation, materials properties analysis and process control. Teams of qualified researchers at C-SOPS use cutting-edge methodologies to address fundamental scientific challenges and to apply this knowledge to develop and optimize new manufacturing methods. Headquartered at Rutgers University, C-SOPS partners include the New Jersey Institute of Technology, Purdue University, the University of Puerto Rico at Mayaguez, and more than 40 industrial consortium member companies. C-SOPS has the ability to support manufacturing development from concept to qualification.
CSOPS Facilities- Rutgers
C-SOPS has heavily invested in establishing state-of-the-art infrastructure across our partner academic institutions that will play a critical role, not only on sustainability, but also on the future of pharmaceutical manufacturing.
The C-SOPS headquarters, at the Rutgers Pharmaceutical Engineering facility, houses over 15,000 sq. ft. of laboratory space specifically designed for pharmaceutical manufacturing research, including GMP-quality seamless epoxy flooring and an environmentally-controlled laboratory capable of reproducing moisture and temperature conditions used in pharmaceutical manufacturing. This research facility currently contains extensive powder characterization and processing equipment that are used by virtually all major pharmaceutical company for the development of new products – a combination almost never found in engineering programs at educational institutions. In addition, CSOPS at Rutgers also features the 2,000 sq. ft. Continuous Pharmaceutical Advanced Manufacturing Laboratory (CpAML), a fully integrated, control-enabled, commercial scale pilot plant for continuous manufacturing. This facility, which is the only one of its kind at a university anywhere in the world, is capable of manufacturing pharmaceutical products by any of the major modes (direct compression, wet granulation, roller compaction, and hot melt extrusion, as well as capsules). The equipment comprises a number of major units (three blenders, 10 feeders, two roller compactor, two tablet presses, a continuous granulator, a continuous drier) that have been received (mostly as in-kind contributions of ERC industrial members), and a seamless floor and air handling equipment. In addition, CpAML is also equipped with specialized equipment, controls, and safety interlocks designed to eliminate the safety hazards associated with the explosivity of powder/air mixtures often encountered in processing. The Rutgers facility served as the model for the INSPIRE facility by Janssen in Gurabo, Puerto Rico, and has been also the starting design point of numerous other facilities at companies around the world.
The CSOPS facilities at Purdue University comprises of the new pilot plant, an 1800 sq. ft. of flexible high bay space that is designed to handle particulate material with minimal exposure to operators by virtue of the dust containment system installed. The solid dosage form manufacturing line includes continuous dry and wet granulation equipment, thereby providing additional versatility in processing raw materials that are not amenable to direct compression. The different unit operations are housed in negative-pressure containment modules, which are directly connected to the dust collector to minimize operator exposure. The pilot facility is also equipped with a clean room maintained under negative pressure to be used for powder preparation prior to processing. The integrated manufacturing line are interfaced with different sensors along the production line to provide an eye into the process for enhancement of process understanding. The real-time sensors include instruments for measuring particle size, density, moisture content and blend uniformity. In addition, Purdue also houses a dedicated Test Bed 3 facility which is a 641 sq. ft. of lab space fully equipped to make drug products by solvent deposition and melt deposition (also called melt extrusion) with real-time monitoring and closed-loop process control. Additional 2000 sq. ft. of particle characterization laboratory is also available at Purdue that contains a wide selection of instruments for measuring raw material attributes and properties of intermediate and final products.
C-SOPS Facilities - NJIT
Center facilities at NJIT comprise of the 1,500 sq. ft. of laboratory space with full ventilation and wet lab facilities for housing novel particle processing instruments. The main space is dedicated to Test Bed 2, a closed-loop continuous oral film manufacturing facility that focuses on thin-film drug delivery systems that offer many advantages such as ease of delivery and patient compliance. Research focuses on techniques for forming precisely controlled release profiles that exploit particle engineering for direct incorporation of API particles into three-dimensional edible substrates which are about 100 microns thick. In addition, NJIT partner faculties have access to the New Jersey Center for Engineered Particulates (NJCEP) laboratories, the Particle Engineering Laboratory as well as NJIT’s Material Characterization Laboratory (MCL).