Launching a state-of-the-art facility focused on filling critical gaps in manufacturing cell and gene therapy — revolutionary yet complex treatments with the potential to change medicine — is no easy feat. It’s a given that it takes years of planning, millions in financial resources, a focused business model and ample technical and regulatory expertise.
But perhaps the most crucial component is a group of people who are truly passionate about getting cell and gene therapies to patients.
Among the esteemed group credited with making BioCentriq a reality is Haro Hartounian, senior vice president and general manager of New Jersey Innovation Institute’s (NJII) Biopharma Division. This past October, NJII (virtually) cut the ribbon on BioCentriq, the first fully cGMP cell and gene therapy contract development and clinical manufacturing center located on a university campus in the U.S.
Along with his industry knowledge and tireless work ethic, it was Hartounian’s dedication to the promise of cell and therapies that invariably attracted the attention of global pharma leaders, technology developers, academic heads and top federal regulators, all of whom came together to make the dream of BioCentriq a reality.
The ribbon cutting event featured glowing remarks from New Jersey Governor, Phil Murphy, as well as a panel discussion with members of NJII’s prestigious advisory committee — also established by Hartounian. The committee boasts a suite of industry leaders including a familiar name in pandemic response, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA).
“One of my great passions is in advancing cell and gene therapies because I believe these are the wave of the future,” said Marks, who also serves as NJII’s FDA liaison, during the ribbon cutting presentation. “The science has moved ahead magnificently over the years but the technology — that is, how we go about making these things — has not kept pace.”
Developing and manufacturing cell and gene therapies consistently, efficiently and at-scale has not only slowed their market entry but also has resulted in costs that are too prohibitive for most patients — but the team at BioCentriq has set out to change this.
Filling a big need
BioCentriq has two facilities: A process development pilot plant in South Brunswick, New Jersey that has been supporting projects since late 2019, and its newest addition, a fully validated, GMP, ISO-7 certified clinical manufacturing facility located on the campus of the New Jersey Institute of Technology (NJIT) in Newark, New Jersey.
Because the center is owned by NJII, a non-profit subsidiary of NJIT, BioCentriq has an ideological calling to help solve the significant manufacturing challenges facing the industry. This purpose has rallied a lot of support from the industry, some of which came in the form of grants from organizations like the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and generous contributions of equipment and funding from several corporate partners.
This invariably was a factor in the remarkable speed in which the new clinical manufacturing facility was built — from beginning construction to completed validation, the facility was finished in just 12 months.
The new 4,000-square-foot facility includes two grade B cleanrooms containing a total of five fully equipped laboratory benches. It offers varied automated cell manufacturing stations, analytical testing laboratories and cryogenic storage. The two controlled-access GMP suites are designed to process multiple patient samples and have dedicated HVAC systems.
The need for facilities that can safely, quickly and cost-effectively manufacture clinical grade material for investigational trials has perhaps never been greater in the pharma industry.
In 2020, the global preclinical and clinical pipeline for cell and gene therapies consisted of over 2,600 studies and trials. While this is good news for patients, is has also caused a scramble for resources and serious capacity bottlenecks for manufacturers with cell and gene therapy capabilities.
For example, the biopharma industry is currently experiencing unprecedented demand for viral vectors, which are commonly utilized as a reagent or the therapeutic agent in cell and gene therapies, respectively, as well as the basis for some vaccines. Experts at CRB, an engineering firm, recently estimated that pharma companies using a CDMO to produce the viral vectors needed to develop new therapies typically face a wait list of as much as 16-18 months.2
BioCentriq has a dedicated production suite for viral vector manufacturing. The center also offers interactive, online courses on the design and manufacturing of viral vectors for gene therapy.
“Many of the larger CDMOs are focused on manufacturing vaccines for COVID-19. In fact, it is estimated that there is only 5-10 percent of contract manufacturing capacity left,” says Hartounian. “That makes BioCentriq a good candidate for the companies that are working on non-COVID cell and gene therapy projects. We can provide capacity right now.”
• Known as the “gateway to the Northeast” New Jersey’s central location gives strategic access to other bio hubs, such as Philadelphia and Boston.
• New Jersey is home to the most (139) FDA-registered biopharma manufacturing facilities in the U.S.
• Nearly 23,000 members of the state’s life sciences workforce are focused on pharma manufacturing — that’s three times the national average.
• New Jersey has the largest concentration of scientists and engineers per square mile in the U.S.
Courtesy of Choose New Jersey
New facility, new business model
With the demand for contract capacity so high, it’s easy to see how smaller pharma companies could be left behind. Hartounian says this is not the case at BioCentriq.
“Our business model is totally different than typical CDMO models. We are very cost-effective, which makes us very attractive to startups and small biotech companies that have limited resources,” says Hartounian. “We treat every company equally. We aren’t looking at their market cap.”
In addition to the more traditional contracting model, BioCentriq also offers a hybrid “hoteling” model which allows client teams to join BioCentriq staff during the project in order to further facilitate knowledge transfer.
In an industry known for being fiercely protective of intellectual property (IP) rights on its products, the idea of a hybrid development model could raise red flags. But BioCentriq addresses this concern at the core of its offerings.
“When clients come into our facility and work with us, they own the rights to whatever IP is generated,” assures Hartounian. “All processes or products developed in our labs on behalf of our clients are the property of our clients alone.”
Intellectual property rights are often a negotiation pain point between pharma companies and outsourcing partners. Shared IP rights could tie a pharma company to a newly improved process being used to manufacture its products, which could mean milestone and royalty payments to the CDMO, thus increasing the cost of the treatment. Removing IP as an issue upfront creates an environment conducive to developing and manufacturing drugs faster and more affordably.
With a mission to support industry-wide advancement of cell and gene therapies, BioCentriq has set its sights on another industry hurdle: workforce development.
Facing a limited biopharma workforce and intense competition for talent, the industry is scrambling to train current and future employees. And since manufacturing cell and gene therapies often involves the use of new technologies and methodologies, this adds an extra layer of complexity to workforce development, requiring the need for additional, specialized training.
“For example, if you look at the New Jersey pharma industry, they’ve been historically strong in solid dosage drugs. But cell and gene therapies are different, so you have a lot of employees that need to get retrained in cell and gene therapy processing,” says Hartounian.
BioCentriq, in collaboration with pharma companies and funders such as NIIMBL, provides both general and customized training in cell therapy and biologics manufacturing.
NJII’s customized training, which pre-dates BioCentriq, started in 2018 when the institute collaborated with New Jersey-based Celgene (now part of Bristol-Myers Squibb) to develop a customized curriculum focused on training in the scientific and engineering fundamentals of cell therapy.
“What makes our workforce development approach unique is the that we tailor and customize the training based on client needs. We’ve been very successful helping the companies to address their workforce development challenges,” says Hartounian.
In conjunction with BioCentriq, NJIT is one of the few universities in the country able to offer a professional science master’s degree program and professional graduate certificate in cell and gene therapy.
“We help the university to tailor the courses based on the industry’s needs. People who come from industry to get their master’s look at the syllabus and the courses and see skills relevant to them on a daily basis,” says Hartounian.
Ultimately, the goal is for BioCentriq to use its experienced staff and facilities to create a hub for joint workforce development programs and training in biologics and cell therapy.
Staffed with a team of engineers and scientists with over a century of collective industry experience, BioCentriq, according to Hartounian, is simply “designed to overcome challenges.”