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The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.
The New Jersey Innovation Institute (NJII), a New Jersey Institute of Technology corporation, and Rutgers University announced plans on Oct. 16, 2017 to form the New Jersey Continuous Manufacturing Institute (NJCMI). The NJCMI’s goal is to advance innovative manufacturing technologies in the pharmaceutical industry.
The institute serves as a center of excellence by combining technologies, infrastructure, facilities, and technical expertise to support the development and continuous manufacturing (CM) of products for the pharmaceutical industry. It will also provide training, education, and workforce development solutions to bolster expertise in the industry for pharmaceutical manufacturing.
The facility features process development pilot plants for both solid-dosage forms and biologics as well as cGMP suites for production. The facility also provides individual unit operations labs for process optimization and control, modeling, and automation. Additionally, it offers designated classrooms and training labs for collaborative learning experiences and workforce development.
“This partnership with Rutgers builds on [more than] a decade of leading-edge R&D and deep faculty expertise that NJCMI can leverage to make available pilot-scale technologies that meet pharmaceutical industry demands for higher production volume, greater efficiency, and reduced cost. I expect the center will be a strong magnet attracting all the links of the pharmaceutical value chain to make New Jersey a place of business,” said Dr. Donald H. Sebastian, president of NJII, in a company press release.
Dr. Christopher J. Molloy, senior vice-president, Rutgers Office of Research & Economic Development added in the release, “NJCMI brings together a complete range of expertise and knowledge to develop innovative biopharmaceutical processing technologies. Our team is led by a core of professionals with more than 100 years of combined experience in biopharmaceutical manufacturing process development, biochemical, and chemical engineering. Together, Rutgers and NJII, through the NJCMI, are meeting the challenges for cost-effective approaches to the continuous production of both new and existing classes of pharmaceuticals.”
Dr. Fernando Muzzio, director of the Center for Structured Organic Particulate Systems (C-SOPS) and of NJCMI, remarked in the release that “continuous manufacturing is an exponentially growing trend leading the modernization of pharmaceutical manufacturing. For large research-based companies, the main need is to develop consensus best practices supported by regulators worldwide. Generic companies, contract manufacturers, and smaller pharmaceutical companies need access to development facilities equipped with all the necessary knowledge regarding product and process development. NJCMI will meet this need, enabling dozens of new players to enter this [market].”
“NJCMI is working closely with our biotechnology partner companies and applying our many years of experience in biologics manufacturing to implement continuous processing innovations. This enables biotechnology companies to produce high-quality products with a smaller production footprint and shorter lead times,” added NJII’s executive director, Biotechnology & Pharmaceutical Innovation, Dr. Haro Hartounian, in the press release.
In related news, C-SOPS held its annual industry meeting at Rutgers University on Oct. 16–17, 2017 where representatives from the partnership presented work already done and future plans to educate regulators and industry members about advances in and best practices for the implementation of continuous manufacturing for both solid-dosage drug products and biologics. This marks the first annual meeting that was open to the industry and the community, as well as to consortium members, in an effort to reach a broader audience.
Source: New Jersey Innovation Institute