Companies in every sector are realizing that manufacturing matters. For the biopharmaceutical industry innovation is not about reducing unit part costs, instead, process technology is a strategic tool to reduce time to market, ensure consistent product quality and streamline regulatory approval. As rapidly as science is advancing drug discovery, so too, must production technology keep pace, but where will such innovation happen? The New Jersey Innovation Institute (NJII) is answering this question.
The Biotechnology and Pharmaceutical Innovation iLab at NJII provides a collaborative platform for industry, technology developers, academia and regulatory agencies to develop, integrate and demonstrate manufacturing solutions. It will also train the workforce to operate next-generation production systems for this industry. Haro Hartounian, Ph.D., NJII’s Executive Director Biotechnology & Pharmaceutical Innovation, is leading the Biotechnology and Pharmaceutical iLab which announces two related centers tackling the priorities of bulk and low volume production for small molecule, biologic and cell-based therapies.
The Continuous Pharmaceutical Manufacturing Center of New Jersey (CPMC) is a joint venture between NJII and Rutgers University that builds on a decade of pioneering work by Fernando Muzzio, Ph.D., Distinguished Professor of Chemical and Biochemical Engineering at Rutgers University. His National Science Foundation Engineering Research Center for Structured Organic Particulate Solids (CSOPS) has led the way in advancing small molecule continuous manufacturing and is extending these methodologies to biologics in this new center. His multi university team has already assisted in commercializing continuous manufacturing of new solid dose therapies with order of magnitude scale reductions in process footprint and capital expense, while also taking years off the manufacturing development and approval process.
NJII’s Cell and Gene Therapy Development Center of New Jersey will offer process development and training and workforce development solutions to the industry for this rapidly developing market. While the CPMC addresses the challenge of mass production through continuous processing, these therapies are more likely to be patient specific and yet still require cost-effective production technology if they are to scale to market need. The Center brings together big pharma, emerging bio-techs, equipment vendors and instrumentation companies together with regulatory agencies to pioneer such development and train those who will take the technology into commercial practice.
By combining state-of-the-art technologies, infrastructure, facilities and know-how both centers have the potential to significantly reduce the cost of manufacturing for both existing and new categories of advanced biopharmaceuticals. The facility will have a pilot plant for process development, training labs and rooms
Advances in biopharmaceutical products have entered a new era of discovery
and treatment. Products only dreamed of a few years ago are now a reality and offer unprecedented promise for the treatment of a wide range of diseases. NJII’s Cell and Gene Therapy Development Center of New Jersey and the Continuous Pharmaceutical Manufacturing Center of New Jersey are dedicated to working with the world’s leading pharmaceutical manufacturers to bring these new medicines to all, faster and at reduced cost to produce.
The New Jersey Innovation Institute (NJII) is an NJIT corporation that applies the intellectual and technological resources of the state’s science and technology university to challenges identified by industry partners. Through its Innovation Labs (iLabs), NJII brings NJIT expertise to key economic sectors, including healthcare delivery systems, bio-pharmaceutical production, civil infrastructure, defense and homeland security, and financial services.
About Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey, is a leading national research university and the state of New Jersey’s preeminent, comprehensive public institution of higher education. Established in 1766, the university is the eighth oldest higher education institution in the United States. Nearly 69,000 students and 22,000 full- and part-time faculty and staff learn, work, and serve the public at Rutgers locations across New Jersey and around the world. The university belongs to the Big Ten Academic Alliance, comprised of 14 world-class research universities, and is among the top 20 public U.S. universities for total R&D funding. Rutgers University–New Brunswick is the state’s only public institution in the prestigious Association of American Universities.