[Q&A] Expanding Capacity and Talent in the Cell and Gene Therapy Industry

[Q&A] Expanding Capacity and Talent in the Cell and Gene Therapy Industry

In this interview, we speak with Haro Hartounian, senior vice president and general manager of BioCentriq about the founding of the company, what is driving the need for expanded capacity and strategies to ensure the right talent is available.
Q: How did BioCentriq get its start and what is your focus?

A: The concept of launching something like BioCentriq started three years ago. There were a lot of products that companies were developing in cell therapy and gene therapy, and being in New Jersey, we felt that eventually these companies were going to need some sort of center where they could come to develop their product or even produce clinical- grade materials for their clinical trials.  I was able to convince the New Jersey Institute of Technology (NJIT) to invest in this concept and persuade technology development companies to make in-kind donations.  We then started construction of the facility. 

Q: It took a lot of networking to make this happen. What’s your background?

A: I have a PhD in chemical engineering, and I’ve been in the industry for 30 years, working for big pharma, mid-sized biotech companies, and I helped found three start-up companies.  Three and a half years ago, I joined New Jersey Innovation Institute; a non-profit subsidiary off NJIT.  BioCentriq was created by the New Jersey Innovation Institute.  I’m also an adjunct associate faculty at Columbia University.  I teach biopharmaceutical product development courses and biotechnology courses, and I’m also an affiliated faculty member of the College of Arts and Sciences at NJIT.

Q: Tell me a little bit more about the facility. 

A: If you look at capacity right now, most of the CDMO’s are focused on COVID-19 vaccine production.  Companies that have products in cell and gene therapy are looking for a center like BioCentriq because there is only five percent of capacity left in the market right now.  This makes BioCentriq very attractive for small biotech companies especially, but also big pharma.  Our clinical production facilities have been qualified by the FDA and our processes are ISO 7-certified. There are two clean rooms with different air handling systems, and another section of the facility which is the process R&D pilot plant. It’s important to note that we are equipment-agnostic.  Any type of cell therapy, gene therapy equipment that you can imagine, we have it in our pilot plant and available for clinical production. And, if we don’t have it, we’re willing to discuss the best possible approach to acquiring it.

Q: If your capacity is stretched, where do you go from there?  Have you got room to expand?

A: We just launched this facility recently and signed a couple of major agreements in the clinical production side as well as process R&D.  As an entrepreneur myself, I really wanted a track record first before we talk about expansion.  With these projects, we will demonstrate our capabilities. We believe that our center will be expanded in the next three years.  We’ll provide services for a larger community of regenerative medicine companies in New Jersey, nationally and internationally.

Q:  What do you see as the challenges and opportunities that are facing cell therapy right now?

A: Honestly, I think the challenge that cell and gene therapy manufacturing people are facing right now is the workforce. They cannot hire people. There is a shortage of people in process engineering, manufacturing, regulatory affairs, quality.  The technical challenge that they’re facing is mostly in the cost of goods.  It’s a very labor-intensive process, but companies are working on automating it, and there are some technologies out there with a fully automated process for cell therapy. I think eventually that some processes, for example, leukapheresis, can be standardized.  They can standardize some of the processes in unit operations.  They can maybe fully automate the manufacturing and cell therapy manufacturing.  It’s going to take another, I would say five, six years to address those challenges and make it easier for the companies to manufacture their product and make it more accessible for patients.

Q: You talked about the workforce. Tell us about how you’re addressing that challenge via education?

A: Every company is looking for process engineers, biologists, scientists, and there are not many of them out there.  So, we’ve been training employees that work in big pharma, that have worked on solid dosage forms or biologics but haven’t worked on cell therapy. We’re retraining them, so they can reposition.  We have viral vector production and process development training as well.  We also launched a master’s program in cell and gene therapy sciences at NJIT.  Professionals from industry with a bachelor’s degree can come and get their master’s degree in cell and gene therapy.  To me, this is very important.  I’m an entrepreneur.  I build companies.  I’m a technical guy.  But also, I’m a teacher.  I teach in the university, so for me, workforce development is essential.

Q: On the topic of workforce development, are you recruiting at the moment?  Are there particular types of roles that you’re looking for or types of people?

A:  Yes.  We are constantly expanding.  We’re hiring people in process R&D, with a biochemical, chemical engineering background.  Biochemists, biologists.  Quality control and quality assurance, regulatory folks.  Our door is open for talented people to come and help us make BioCentriq more successful. We are looking for people who are excited about cell and gene therapy and excited about helping the patients. At the end of the day, those are the people we want to come and work for us.