Dr. Haro Hartounian is senior vice president and general manager of the Biopharma Division of the New Jersey Innovation Institute (NJII). The division, founded in 2015, includes a state-of-the-art cell and gene therapy development center branded BioCentriq, a workforce development program dedicated to closing skill gaps that exist in the industry, and a unique incubator-like program called the BioFoundry that works to make sure innovative companies with viable therapies get the support they need to grow.
What’s unique about BioCentriq?
BioCentriq is going to be the newest process development and clinical manufacturing organization (CDMO) in the country when it opens this summer. It’s also the only one in the U.S. backed by a university, and the only facility of its kind in Newark, NJ.
NJII is a 501(c)3 non-profit corporation owned by NJIT. As a non-profit we can offer services at a lower price point than our commercial counterparts which makes us an attractive option for large established biopharmaceutical firms who want to find an affordable option for particular projects in their pipeline as well as startup or mid-sized firms who are moving to prepare their therapies into clinical trials. What’s key is that we allocate resources fairly, treating small startups with the same attention we give large, globally known clients.
We are also flexible in regards to working relationships. We welcome partners that wish to work on-site in our facilities side-by-side with our researchers on a pre-competitive group-sponsored project, but can also take on traditional fee-for service work for companies that want to focus their resources elsewhere. In any instance, intellectual property remains solely with the client. We want our customers to consider us as their clinical supplies partner, not just a CDMO.
BioCentriq has two main arms — process development and clinical manufacturing.
How does process development work?
During the cell or gene therapy development cycle, lab-scale processes need to be developed into efficient, closed systems that can be consistently reproduced at scale. This is where we come in.
Process development is about developing a system for advancing the cell or gene therapy. We discuss the problem with the companies. What is the product? What is the indication? How do you make it a closed system? How can we efficiently automate it for larger-scale manufacturing and determine the best way to proceed to clinical manufacturing
What are BioCentriq’s clinical manufacturing capabilities?
We have a new, FDA-compliant Current Good Manufacturing Practice (cGMP) manufacturing facility undergoing final construction on the top floor of NJIT’s Life Sciences and Engineering Center in Newark. It features two cutting-edge cGMP suites, one for gene therapy and one for cell therapy.
And, when I say our facilities are cutting-edge, I mean it. We have all the process development, analytical, clinical manufacturing and quality systems from the leading developers installed in our facility.
We’re playing a part in developing medicines of the future, where treatments are derived from a patients’ own cells to be perfectly tailored to their needs. This is the reason we’ve been able to attract so much top talent to our advisory committee, such as chairperson Dr. Joanne Beck, the chief operating officer of Boston Pharmaceuticals; Dr. Kelvin Lee, the director of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL); and Dr. Steve Dziennik, the director of Global Technical Operations Biologics at Merck. In addition, Peter Marks, the director of the FDA’s Center For Biologics Evaluation and Research (CBER), serves as a liaison to the agency.
What kinds of companies do you work with?
We cannot disclose the names of clients, but we can say we’re working on three projects with big, public, pharmaceutical companies, plus two projects with mid-sized companies, and one with an innovative startup.
At full capacity, we could take on six or seven clinical manufacturing clients and 10 or so in process development, so there’s room to grow while ensuring each client gets the attention they need. We’re also indication agnostic, and welcome clients doing any sort of cell or gene therapy development.
We are currently qualifying and validating BioCentriq’s manufacturing processes, facility, and equipment to ensure they meet and exceed industry standards. This is being capably handled by our new director of Quality Compliance and Training Development, Mahezabin Tai. She is addressing change and audit management, document control, and will oversee compliance training.
What are you doing in the area of workforce development?
This is another area where having the full support of NJIT is integral. We launched a 30-credit Master’s program in cell and gene therapy at the university in January of this year. It is part of NJIT’s Department of Chemistry and Environmental Science. Along with the Master’s, we built a related four-course, 18-month apprenticeship certificate program that gives select students access to the kind of exciting technology I mentioned earlier.
There’s a huge and growing need for professionals in the cell and gene therapy area, as well as biopharma overall. They all have to be meticulously trained. We’re very happy to be part of a top-ranked university that takes that need seriously and provides both class work and hands-on learning. In addition, we have ongoing collaborations with big pharma clients to train their incoming workforce. These programs have been tremendously successful and have been going on for more than a year and half.
What is the BioFoundry?
BioFoundry helps startups and other companies looking to scale up and connects them with capital, vetted talent, and established tech professionals that can provide mentoring. It was created following the December, 2018 awarding of a grant from the U.S. Economic Development Administration, through its Regional Innovation Strategies (RIS) Program. My deeply skilled team at NJII manages it.
BioFoundry has connections with 33 universities throughout the state, and has helped almost a dozen companies to date. It works because startups need funding and the right connections to grow. If you are a growing company in need of funding, or mentor guidance, contact Dr. Chathuranga De Silva, Biopharma’s director of business development.
I’m extremely proud of our team. Our dedicated and focused experts are passionate about the work we’re doing, and they are accomplishing great things. I’m also very appreciative of the support we receive from NJIT and NJII, as well as other organizations such as ChooseNJ, ARM, BioNJ and NIIMBL. We all have the same mission, which is to ensure that the resources we have to offer here in New Jersey, and really across the United States and around the world are utilized to advance one of the most promising forms of treatments — cell and gene therapies.
We are also an open and collaborative group. Your mission is our mission. Talk to us. If you want to get involved in supporting our workforce development efforts, we want to hear from you. We are exploring some very intresting partnerships with several industry leaders and developing exciting new programs we hope to be able to announce soon. We are open to these kinds of conversations.
If you have a project that’s in any stage of development, talk to us — we may have a customized solution for you. We can explain how it can be run in our center and provide you with a quote. Our center opens this summer, and as of right now, in early May, we still have room to sign on a few more projects to get underway when we are fully operational.
Lastly, if you can’t think of a reason for us to talk right now, but you are in the industry and want to stay up to date on what’s going on in our division, just visit our website and ask to be added to our mailing list. We send out a monthly newsletter that will keep you informed, and hopefully we’ll find a way to work together soon.
To learn more about the Biopharma Division at NJII please visit njii.com/biopharma.