BioCentriq first was launched in 2019 by NJII, a New Jersey Institute of Technology (NJIT) corporation that was created in 2014 to serve as a portal and platform for higher education/industry partnerships. NJII brings together the capabilities of NJIT, industry and government relationships, and proven methods to build industry-centric ecosystems that foster innovation and deliver solutions that make a direct impact on the economy and improve the quality of life.

“Thanks to the foresight of the NJIT Board of Trustees in supporting the creation of NJII, we were able to create an entity that has built upon NJIT’s strengths in life sciences and engineering to serve as a catalyst for entrepreneurship and industry partnership,” said NJIT President Joel S. Bloom.

NJII CEO Simon Nynens explained, “This is a perfect example of what NJII was designed to do. In this case, we were able to work with industry to identify an area of huge need and create an entity that delivers a solution.”

NJII initially began exploring the sale of BioCentriq through a bid process that involved more than 50 companies, and the terms of the deal and its closing were approved recently by the NJII Board of Directors. The members of the NJII Board include a broad range of industry, government, and higher education leaders. The proceeds of the transaction will be held by NJII and redeployed to continue growing an innovation and entrepreneurship ecosystem that supports the State of New Jersey and its regional economy.

Dr. Haro Hartounian, SVP and GM of BioCentriq, noted, “I would like to thank NJIT and NJII for providing the opportunity to start BioCentriq and to build a successful Contract Development and Manufacturing Organization. This transaction marks the start of an exciting new chapter for BioCentriq. This acquisition by GC. will enhance BioCentriq’s ability to deliver superior service and expertise for cell and gene therapy companies. BioCentriq and GC’s combined expertise and synergy will enhance our ability to drive innovation in cell and gene therapy that delivers life-changing therapies for patients who so desperately need them.”

GC is a South Korean company founded in 1967 with a major footprint across healthcare sectors. “BioCentriq’s unique expertise in the rapidly growing cell and gene therapy CDMO will be a transformative addition to our business that we believe will accelerate our growth, with additional expansion projects underway in New Jersey. We are thrilled to team up with BioCentriq’s incredibly talented team,” said Yong-Jun Huh, the company’s president.

Moving forward BioCentriq will operate in a mode similar to other GC companies, with each
maintaining its individual culture and identity while sharing best practices. Dr. Haro Hartounian, SVP and GM of BioCentriq, will become the CEO of BioCentriq upon the closing of the transaction. He will retain his position as affiliated faculty at NJIT.

“We thank Haro and his entire team for all their hard work and wish them continued success,” Nynens added.

Bloom added, “NJII’s sale of BioCentriq to GC. is a tremendous success story and a prime example of how effective collaboration between higher education, industry, and government can lead to innovations that positively affect the health and wellbeing of people while also driving economic growth.”

About BioCentriq:
BioCentriq is a full service Contract Development and Manufacturing Organization (CDMO). BioCentriq’s mission is to accelerate the advancement of cell and gene therapies by improving the efficiency and effectiveness of manufacturing processes and technologies.

About NJII:
New Jersey Innovation Institute (NJII), an NJIT corporation, was founded in 2014 and helps turn ideas into workable solutions across four divisions: healthcare, entrepreneurship, defense and homeland security, and professional and corporate education. NJII combines the vast resources of NJIT, strong and far-reaching industry and government relationships, and proven methods for building industry centric ecosystems to help drive innovation and deliver solutions that make a direct impact on the economy and the health and welfare of its participants.

About GC:
GC (formerly known as Green Cross Holdings), through its operating companies, provides total healthcare solutions that address the evolving needs of human health. GC was founded in 1967 and is headquartered in Yongin, South Korea.

The post NJII Announces the Sale of its Subsidiary, BioCentriq, for $73 Million appeared first on NJII.

“We are honored to partner with McKinsey & Company who will contribute their thought leadership and expertise in operational excellence to design this center and develop and deliver the curriculum,” said Haro Hartounian, SVP and general manager of the Biopharma Division of the New Jersey Innovation Institute. “Our mission is to make cell and gene therapies more accessible to the patients that need them, and this center will provide an opportunity for companies from around the world to experience innovative and promising Industry 4.0 approaches and technologies first-hand.”

According to the Alliance for Regenerative Medicine’s annual report there are more than 1,085 total gene, cell and tissue-based therapeutic developers worldwide and 1,220 trials aiming to enroll more than 90,000 patients worldwide. In order for these therapies to become more accessible, the manufacturing of them must become more efficient, and the technology and digital and operational approaches being introduced in the Digital Capability Center are widely anticipated to be the key enablers of those improvements.

McKinsey & Company launched its worldwide network of Capability Centers in 2007. These immersive learning environments inspire and equip organizations to deliver sustainable performance improvements from operational excellence and tech-enabled transformations, with centers in Aachen, Atlanta, Beijing, Gurugram, Istanbul, Salvador, Singapore, Monterrey, and Venice This new center will open at the VentureLink building on the campus of NJIT in Newark, New Jersey in the 4th quarter of 2021 and will be supported by BioCentriq, NJII’s full-service concept-to-clinic contract development manufacturing organization (CDMO) founded in 2019 with a mission to help innovative companies reach clinical success.

About NJII

The New Jersey Innovation Institute (NJII) was founded in 2014 and combines the vast resources of NJIT, strong industry and government relationships, and proven methods to drive innovation and deliver transformative products and services. To achieve this, NJII is organized into six innovative divisions that guide our activities: biopharma, data and advanced technology, defense and homeland security, entrepreneurship, healthcare delivery and professional and corporate education. Learn more at www.njii.com.

About McKinsey & Company

McKinsey & Company is one of the world’s leading management consulting firms. For over 90 years, we have helped clients across the life sciences sector achieve substantial, lasting improvements in business

performance. With exceptional people in over 65 countries–including medical doctors, engineers, designers, data scientists, business managers, entrepreneurs, and research scientists–we combine global expertise and local insights to help our clients create not just change, but Change that Matters.

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Media Contact:
Amy Lamperti
VP, Commercialization
amy.lamperti@biocentriq.com
+1-201-572-1554

The post NJII Launches New Digital Capability Center for Cell & Gene Therapy on Campus of NJIT appeared first on NJII.

NEWARK, NJ, June 22, 2021 – CaroGen Corporation has selected BioCentriq as their partner for clinical manufacturing to support Phase 1 clinical trials of its lead immunotherapy candidate, CARG-201 which has been designed to stimulate the immune system and generate multiple hepatitis B virus (HBV) antigens. VLVs used by Carogen are an artificial hybrid virus based on an alphavirus RNA replicon and glycoprotein from vesicular stomatitis virus.

“CaroGen’s mission is to develop transformative immunotherapies that will recognize and fight infectious diseases of unmet need, like those generated by HBV, that result in chronic liver conditions and cancer” said Bijan Almassian, Ph.D. and CaroGen’s CEO. “We are thrilled to have the opportunity to engage an expert and innovative partner like BioCentriq to help validate our methods, further develop our manufacturing processes and ultimately produce high-quality clinical grade materials.”

BioCentriq is a New Jersey based full-service concept-to-clinic contract development manufacturing organization (CDMO) with a mission to support innovative companies reach clinical success. The company offers process development and clinical manufacturing services for the cell and gene therapy industry along with a workforce development arm designed to help the industry adopt best practices in cell and gene therapy manufacturing.

“Our team is enthusiastic about the opportunity to help CaroGen scale up their technology and manufacture clinical grade materials that can be made available to the patients who need them the most” said Haro Hartounian, Ph.D., SVP and general manager of BioCentriq. “The work that CaroGen and the team at Yale University has done is truly impressive and we are honored to partner with them as they enter Phase 1 clinical trials.”

CaroGen is a private biotechnology company with a patented and transformative novel immunotherapy and vaccine platform called AVIDIO, or Artificial Virus for Infectious Diseases and Immuno-Oncology. The AVIDIO platform technology was licensed from Yale University for worldwide use by CaroGen for both prophylactic and therapeutic vaccine applications.

According to the Hepatitis B Foundation more than two billion people around the world have been infection with the hepatitis B virus and 30 million people become newly infected each year. The Foundation asserts that HBV is the leading cause of liver cancer and nearly 884,000 people die each year from hepatitis B and related diseases.

About CaroGen

CaroGen Corporation is an immunotherapy company employing a virus-like vesicle (VLV) platform technology that was pioneered by Professor John Rose at Yale University School of Medicine and is exclusively licensed by CaroGen for the development and commercialization of VLV immunotherapies worldwide. CaroGen has completed preclinical proof-of-concept in HBV animal models and selected a clinical candidate, CARG-201. CaroGen also is exploiting its AVIDIO platform technology to create novel immunotherapies prospectively for colorectal, ovarian, and liver cancers in collaborations with medical researchers at Yale University, University of Connecticut, Brown University, Albany Medical College and Wayne State University. www.carogencorp.com.

About BioCentriq

BioCentriq is a cell & gene therapy process development and clinical manufacturing center founded in 2019. The company produces autologous and allogeneic cell therapies and gene therapies, and immunotherapies, including monoclonal antibodies and proteins, and vaccines on behalf of therapy developers. BioCentriq also offers customized workforce development programs. Visit www.biocentriq.com.

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Media Contacts

Bijan Almassian, PhD
President & CEO
balmassian@carogencorp.com
+1-203-815-5782

Amy Lamperti
VP, Commercialization
amy.lamperti@biocentriq.com
+1-201-572-1554

The post CaroGen Partners with BioCentriq™ for Clinical Production of its Virus-like Vesicle (VLV) Immunotherapy for Chronic Hepatitis B Viral Infection (CHB) appeared first on NJII.

VentureLink’s BioFoundry is an early-stage incubator specifically designed for Cell and Gene Therapy startups. BioFoundry empowers and enables founder-scientists launch and transform their research into a full-fledged business with true investment potential. Our team transforms successful scientists into successful CEOs of investable companies. The BioFoundry’s unique mix of interactive programming, founder training, investor pitch coaching, and relationship building is the recipe for successful translational science startups.

Accepted companies access an exclusive network of investors and established pharmaceutical partners, as well as building crucial skills including team building, hiring, commercialization strategy, fundraising strategy and equity management.

BioFoundry companies are engaging the market and furthering the development of their businesses with access to our expert entrepreneurs, alumni network, established pharmaceutical leaders, BioCentriq – NJII’s full-service CDMO – and the VentureLink@NJIT coworking space.

If you are looking to scale-up or apply for a Series A in the next 18 months, BioFoundry offers valuable resources, connects you with capital, vetted talent, and established professionals that can provide mentoring.

Applications for VentureLink’s BioFoundry Incubator will be open on June 15^th (6/15/21) to Cell and Gene Therapy startup founders until August 1^st (7/1/21)!  This 14-week program will run from September to December of 2021 culminating in a showcase to investors and experts.

Investors are invited to connect as well. We scour the United States and beyond for the next big BioPharma startups. See them at the BioFoundry Showcase. Sign up to receive an invite!

For additional information on eligibility and the application process, review the BioFoundry’s page: venturelink.org/biofoundry.

BioFoundry is free and we do not take any equity thanks to the support of the U.S. EDA Regional Innovation Strategies Program and our partners.

The post Now Available: The Business Jet Fuel for Your Biopharma Startup appeared first on NJII.

Virtual ribbon cutting and tour featured remarks from New Jersey Governor Phil Murphy, FDA’s Peter Marks, as well as panel discussions with industry leaders from ARM, NIIMBL, Century Therapeutics, BioNJ, NJEDA, NJIT and NJII on the rise of Cell & Gene Therapy in New Jersey

October 29, 2020 – Newark, NJ – The New Jersey Innovation Institute (NJII) and Choose New Jersey hosted a virtual ribbon cutting, tour and panel discussions to mark the opening of BioCentriq, NJII’s cutting-edge cell and gene therapy development and clinical manufacturing center located on the campus of the New Jersey Institute of Technology (NJIT) in Newark, New Jersey.

New Jersey Governor Murphy’s pre-recorded opening remarks emphasized the important role centers of innovation like BioCentriq will play in a post-pandemic economy.

President of New Jersey Institute of Technology Dr. Joel Bloom reinforced the governor’s message by stating “There is a massive need for what BioCentriq can provide, and our ability to fill that gap will translate into results that literally save and improve the quality of countless lives. We have the capacity to help companies develop processes, conduct clinical production trials, and train employees.”

Jose Lozano, president and CEO of Choose New Jersey hosted the event. “New Jersey is a top hub for cell and gene therapy,” said Lozano. “We are home to groundbreaking cell and gene therapy companies that are leading the way in next-generation therapeutics. Today’s ribbon cutting at BioCentriq is another exciting chapter for New Jersey’s innovation economy. We look forward to seeing how BioCentriq will advance the industry in years to come.”

Opening remarks were made by Joel Bloom, Ed.D. and president of NJIT, Governor Phil Murphy, Robert Cohen, president digital, robotics, and enabling technology at Stryker and Simon Nynens, CEO of NJII.

Pall Biotech, The National Institute for Innovation in Manufacturing Biopharmaceuticals, BMS, Cytiva, Panasonic Healthcare and Novartis were recognized, along with the 12 industry leaders who make up the biopharma advisory council, for their contributions of equipment, funding and expertise.

Dr. Peter Marks, MD., Ph.D., director of the center for biologics evaluation and research (CBER) at the U.S. Food and Drug Administration (FDA) spoke about the importance of cell and gene therapies and the role of the FDA in streamlining, removing hurdles and providing support to improve the availability of these therapies. He also talked about the importance of collaborative efforts like BioCentriq to help accelerate advancements and innovation.

Haro Hartounian, Ph.D. and SVP and GM of the Biopharma Division, and senior vice-president and general manager of BioCentriq, gave a detailed view of the new center and the work being done by the Biopharma division at NJII. Dr. Hartounian also premiered a video tour of the facility. In addition, he led a panel discussion on the future of cell and gene therapy manufacturing with Kelvin H. Lee, Ph.D. director of the National Institute for Innovation in Manufacturing (NIIMBL), Janet Lynch Lambert, CEO of the Alliance for Regenerative Medicine and Greg Russotti, Ph.D., chief technology officer of Century Therapeutics, LLC.

“BioCentriq’s mission is to bring together industry, technology developers, academia and regulatory agencies to help advance the development and manufacturing of cell and gene therapies,” said Dr. Hartounian. “We are thrilled to open the doors to our center at a time when demand for process development and clinical manufacturing of cell and gene therapies exceeds capacity available from existing contract development and manufacturing organizations. Our goal is to provide a collaborative space where innovative approaches and technologies can be utilized to help make emerging therapeutics available to the patients that so desperately need them.”

The event concluded with a panel discussion that featured local leaders who described the resources New Jersey offers to companies who bring their cell and gene therapy projects and businesses to the state. Panelists included Debbie Hart, president & CEO of BioNJ; Jose Lozano; Kathleen Coviello, executive vice president for Technology, Life Sciences & Entrepreneurship at the New Jersey Economic Development Authority (NJEDA); and Kevin D. Belfield, Ph.D. and dean, College of Science & Liberal Arts, NJIT.

To learn more and view the recorded event please visit: https://www.choosenj.com/webinar/first-look-at-biocentriq/.

Shown in above photo of BioCentriq Ribbon Cutting at NJIT Life Sciences & Engineering Center Building in Newark, NJ from left to right are Robert Cohen, president, digital, robotics, and enabling technology, Stryker, Simon Nynens, CEO, New Jersey Innovation Institute (NJII), Joel Bloom, Ed.D., president, New Jersey Institute of Technology (NJIT), Dan Wessner, director of sales, Pall Biotech, Haro Hartounian, Ph.D., SVP and general manager, NJII, Fadi P. Deek, Ph.D., provost and senior executive vice president, NJIT and Jose Lozano, president & CEO, Choose New Jersey.

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Media Contacts:

Amy Lamperti
VP, Business Development & Marketing
New Jersey Innovation Institute (NJII)
Amy.lamperti@njii.com
+1-201-572-1554

Carly Wronko
Marketing Manager
Choose New Jersey
+1-609.297.2189
cwronko@choosenj.com

The post Cutting-Edge Cell & Gene Therapy Manufacturing Center, BioCentriq™ Opens in Newark, New Jersey appeared first on NJII.

Selecting a CDMO is a very important decision, as you aren’t just entering a transactional relationship – you are forming a long-term partnership that can not only impact the success of your current product, but also benefit the manufacturing of future products in your pipeline.

What stage are you in?

One of the first things to think about when evaluating different CDMOs is to consider what stage of the manufacturing process you are in and what your needs are. Typically, your project will fall into one of these categories:

Early Stage

You have a product concept and have done discovery and/or academic research, but you have performed little or no process development or evaluated the scalability of your process. For example, you may currently be working in pre-clinical trials with animal models.

For early stage projects, it is essential that your CDMO offer process and assay development in addition to manufacturing. Their process development equipment and capabilities must provide a smooth scale-up to their manufacturing-level counterparts. Additionally, considering how long the lead times can be for manufacturing, conducting process development earlier will mean your product is well positioned to transition to manufacturing when slots become available, reducing time losses.

Significant Development

You have done internal process development (i.e. bioreactor and purification process work) and are looking to transition to a larger scale production and/or to GMP-grade manufacturing. Having a CDMO with process development capabilities will facilitate the testing and scale-up of your developed process, but the availability of large-scale/GMP production becomes a more important factor.

Advanced Development

You have developed a complete process that has been tested at the desired scale and you aim to transition or expand to a new CDMO. The availability of large-scale/GMP production is likely to be the most important criterion once you have established compatibility between the CDMO’s capabilities and your process requirements.

Evaluate the top 10 “intangibles”

Once you have established what your needs are and what type of CDMO you should work with, the harder part begins: how to choose between the organizations that fit your criteria. While some factors, like CDMO size, available equipment, or process development capabilities, may be easily assessed over the internet or in a short conversation, there are other criteria that, in my experience, can have a deeper, longer-lasting impact on the success of the project and can influence whether or not the relationship will become a strong, long-lasting partnership.

We can refer to these factors as “intangibles”, since they have more to do with the nature of the organization, the way in which communication flows, and the compatibility between your company and the CDMO. Below, I describe some of these intangibles, how they can shape your CDMO search, and what types of questions you can ask to assess them:

1. Speed

How quickly can the CDMO sign a non-disclosure agreement (NDA) so that you can start a more detailed conversation? This process can be as fast as days or a slow as weeks or even a few months. Additionally, how quickly can they produce a quote or a statement of work? It is very important, at the very least, for them to keep the conversation going, even if there are delays in the writing and signing of the documents. If they aren’t moving fast during the scoping and proposal phase, what does that say about their delivery timelines?

2. Capabilities

You have already established whether they offer process development according to your needs. Now, it is time to ask whether they have the adequate capabilities and expertise to work on your process, especially if your system is not the most widely used platform in the field. For example, some CDMOs may have extensive experience with lentiviral vectors but very little work with adenoviral vectors, or a CDMO may have limited experience with fermentations in hosts other than E. coli.

3. Responsiveness

How communicative are they during the project scoping stage? In my experience, a high level of responsiveness during early stages generally translates into good communication throughout the relationship.

4. Availability

How soon can they start working on your project? Can they start working on tech transfer and process development to minimize time losses? This is particularly important when there are long delays for manufacturing space.

5. Flexibility

Do they require you to utilize their process, and if so, are there are IP repercussions? Ideally, the CDMO can adapt to your process, unless they provide a strong justification (e.g. scalability, availability of reagents); this can mean bringing in new pieces of equipment, new reagents, new in-process measurement methods, etc. How do they respond to special requests?

6. Transparency

Do they allow you to visit and inspect their facilities prior to signing an agreement and once the project has started? Are they open to external audits? How do they respond to conflicts of interest?

7. Willingness to Collaborate

Are they willing to work with you as the process is being developed and optimized, and once manufacturing begins? Can the client visit and troubleshoot things together with the CDMO? This is, in my opinion, one of the strongest indicators of a good and healthy partnership, as it can be a measure of how well you will work together and how much the CDMO cares about the success of your project.

8. Confidentiality

How much do they value client confidentiality? How do they act during phone calls and video conferences? For example, do they casually mention other clients by name? Are they careless when sharing screens such that client names are visible in files and folders? When you visit their facilities, do you see papers, notebooks, and other exposed materials that could reveal the names of other clients, or the nature of other processes (i.e. I.P.)?

9. Quality

How would you evaluate the quality mindset of the CDMO? What quality system do they use? How strong is their quality team, and how much experience do they have? How many audits have they had? This is a good opportunity for you to ask the CDMO to describe how they have dealt with quality issues in the past.

10. Compatibility

How compatible is your company with the CDMO? The aspiration is that the relationship will become a long-term partnership and that you may work on more projects together in the future if everything is successful. Therefore, you would ideally want interactions with the CDMO to be cordial, easygoing, and welcoming, particularly during visits.

You should expect any future partner to be responsive and demonstrate understanding when problems arise during process development or manufacture. The bottom line is that you want to look forward to talking to and working with them.

Consider intangibles to create a long-lasting partnership

As more organizations enter the space, making a final decision on which CDMO will handle the scale-up and manufacturing of your product can seem like a daunting task. However, once you identify your needs and potential organizations you can work with, you can research the criteria that will most strongly influence your relationship with the CDMO so that you can make a well-informed decision.

In addition to standard factors like cost and availability, make sure to consider these intangibles, as they can help you assess the level of compatibility between the two organizations and give you an indication of whether your relationship with the CDMO will be well positioned to blossom into a strong, long-lasting partnership and not a transactional relationship.

The post Choosing a CDMO: Top 10 Intangibles Biotech Firms Should Consider appeared first on NJII.

RSVP to attend here.

BioCentriq is NJII’s cell and gene therapy development and clinical manufacturing center located on the campus of the New Jersey Institute of Technology (NJIT) in Newark, NJ.

The event will be emceed by Jose Lozano, president and CEO of Choose New Jersey. Opening remarks will be made by Joel Bloom, Ph.D., president of NJIT, New Jersey Governor Phil Murphy, Robert Cohen, president digital, robotics, and enabling technology at Stryker and Simon Nynens, CEO of NJII.

Dr. Peter Marks, Ph.D., director of the center for biologics evaluation and research (CBER) at the U.S. Food and Drug Administration (FDA) will speak about the critical need for additional capacity for the development and manufacturing of biologics and the complex path to clinical trials for vaccines and cell and gene therapies.

Haro Hartounian, Ph.D. and SVP and GM of the Biopharma Division will provide a more detailed view of the new center for the development and clinical manufacturing of cell and gene therapies and the work of the Biopharma division at NJII.  He will also premier a pre-recorded virtual tour of the facility and take questions about BioCentriq.

Dr. Hartounian will then lead a panel discussion on the future of cell and gene therapy manufacturing with Kelvin H. Lee, Ph.D., director of the National Institute for Innovation in Manufacturing (NIIMBL), Janet Lynch Lambert, CEO of the Alliance for Regenerative Medicine and Greg Russotti, Ph.D., chief technology officer of Century Therapeutics, LLC.

The event will conclude with a panel discussion with leaders who can describe the resources available to companies who bring their cell and gene therapy projects and businesses to New Jersey.

Panelists include Debbie Hart, president & CEO of BioNJ, Jose Lozano, president & CEO of Choose New Jersey, Kathleen Coviello, executive vice president for Technology, Life Sciences & Entrepreneurship at the New Jersey Economic Development Authority (NJEDA) and Kevin D. Belfield, Ph.D., dean, College of Science & Liberal Arts, NJIT.

The event takes place on Thurs Oct 29^th from 2:30 p.m. to 3:30 p.m. EDT.  

Visit https://www.choosenj.com/webinar/first-look-at-biocentriq/  to learn more and RSVP to attend.

The post Virtual Ribbon Cutting of BioCentriq™ Scheduled for October 29th at 2:30pm appeared first on NJII.

BioCentriq is offering a 4-Day Virtual Training October 19-22 on the design and manufacturing of viral vectors for gene therapy.

As of today, there are still several spots available in Intro to the Design & Manufacturing of Viral Vectors for Gene Therapy.

“Our course is designed to create the workforce of the future “stated Haro Hartounian, Ph.D., senior vice-president and general manager, NJII.  “We must help scientists from around the globe gain a detailed understanding of upstream and downstream processing of viral vectors so they can support the incredible demand we are seeing in the market. “

The course, led by NJII and NJIT staff and faculty, includes 16 hours of interactive, live, on-line instruction held over four days.  It will focus on viral vector theory, technical demonstrations of bioreactors, demonstration of chromatography, principles of tangential flow filtration (TFF) and scale-up topics.

Attendance is limited to 20 scientists and engineers from the industry. Class size is kept small to ensure maximum engagement and interaction.  Attendees must have a basic understanding of cell culture, conventional culture methods and chromatography (affinity, protein capture).

Full details on the course can be found here.

The post Viral Vector Market Projected to Grow Exponentially, Increasing Demand for Skilled Workforce appeared first on NJII.

NJII’s advisory committee is made up of a dozen executives from leading pharmaceutical and biotech companies, and is chaired by Dr. Joanne Beck, the chief operating officer of Boston Pharmaceuticals. Peter Marks, the director of the Food and Drug Administration’s Center for Biologics Evaluation and Research is also involved, serving as a liaison to the agency.

“Beth’s expertise in cell and gene therapy commercialization and digital transformation in the life sciences will add even greater breadth and depth to our advisory committee,” said NJII Senior Vice President and General Manager for Biopharma, Dr. Haro Hartounian. “We are so honored to have her on board.”

To learn more about NJII’s Biopharma division please visit www.njii.com/biopharma.

The post Cytiva’s Beth Thompson-Webb Joins BioCentriq’s Advisory Committee appeared first on NJII.

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. 

What else do you want people to know about your division? 

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. 

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