NJII announces creation of groundbreaking gene therapy manufacturing facility

The Biopharmaceutical Division of the New Jersey Innovation Institute announced Tuesday the creation of BioCentriq, a cell and gene therapy production and manufacturing center that will be the only process development and clinical manufacturing facility for cell and gene therapies located on a university campus in the country.

New Jersey Institute of Technology’s College of Science and Liberal Arts Dean Kevin Belfield said the facility goes in line with the university’s mission.

“We are one of the few universities in the country able to offer a Professional Science Master’s degree program and professional graduate certificate in the rapidly expanding field of cell and gene therapy,” he said. “And the only university fortunate enough to be able to provide our students and industry partners the opportunity to take advantage of the process development, clinical manufacturing and workforce development capabilities as well as the experts and equipment resident at BioCentriq.”

NJIT’s Life Sciences & Engineering Center in Newark.

The biopharma division also announced that it has initiated the qualification and validation process for the BioCentriq facility and its equipment. This Good Manufacturing Practice facility is located at NJIT’s Life Sciences & Engineering Center and features two GMP suites.

The GMP suites are expected to complete their qualification and validation and be operational this summer. BioCentriq also offers a process development center, currently located at the Rutgers Medical School in Newark, which has been open and actively supporting projects since late 2019.

Haro Hartounian, senior vice president and general manager of biopharma at NJII, said BioCentriq has created a different kind of highly collaborative environment for this industry.

“Most initiatives underway at universities are run by their professors, who pursue the types of projects they want to do on behalf of grant-writing, their classes and their students,” he said.

BioCentriq is not depriving professors and students, Hartounian adds: “When we have studies or speakers addressing key issues, we invite the faculty members, and they lend their experience and expertise to the workforce training and projects, too. We are giving incredible access to the students.”

Hartounian’s team reached out industrywide, contacting pharma, the Food & Drug Administration, medical technology companies and startup pharmaceutical companies, and asking them what they wanted to study.

“With our approach, we address what’s really pressing in immunotherapy and oncology and areas where cell and gene therapies are making a difference,” he said. “This is our mission.”

The BioCentriq logo.

Work is underway at BioCentriq on cell and gene studies and on developing workforce. But what has Hartounian most excited is this summer’s scheduled opening of the facility.

“Manufacturing is such a vital and often-overlooked aspect for drugs that are being developed,” he said. “Companies develop incredible drugs, but then things bog down and they aren’t manufactured in the timely, efficient way that they need to be. There’s a capacity issue nationwide; supply-chain management is really important.

Hartounian said BioCentriq supports startup companies with product development, trials and helping them to find and hire talent.

“As for smaller startup firms, they just don’t have the infrastructure to do this themselves, especially in competition with the larger players,” he said. “The opening of our center will help address that. And, by bringing in other more established biopharmaceutical companies, we’ll be encouraging collaboration. Other manufacturing centers don’t do that.”

He added: “We are grateful to all our partners who have supported us financially and with in-kind donations of equipment and supplies, as well as the industry leaders who serve on our advisory board and lend us their expertise.”