New Jersey’s vibrant innovation ecosystem has transformed the state into a top hub for cell and gene therapy. The state boasts some of the country’s foremost cell and gene therapy companies and manufacturing facilities that are leading the way in next-generation therapeutics.
The concentration of biopharma companies in the NY/NJ region makes it one of the top 3 innovation clusters in the United States. New Jersey companies and R&D institutes have served as pioneers in the personalized medicine revolution. Gene therapy is the introduction of genes into existing cells to prevent or cure a wide range of diseases, including cancer. The first such therapy was brought to market from New Jersey.
Medical discoveries and innovations, such as antibiotics, vaccinations and imaging, transformed health and longevity in the 20th century, as biopharma is transforming the 21st century. These cutting-edge technologies are changing the trajectory of diseases once thought to be incurable and extending the longevity and quality of lives.
New Jersey is taking a big step forward in the evolving world of cell and gene therapy with the formation of BioCentriq. This state-of-the-art cell and gene therapy process development and Good Manufacturing Practices (GMP) manufacturing center is located on the Newark campus of the New Jersey Institute of Technology (NJIT). The center is dedicated to working with industry to address its needs in process development, manufacturing clinical supplies for clinical trials, and workforce development.
The center is managed by the New Jersey Innovation Institute (NJII), a 501(c)3 non-profit corporation owned by NJIT. NJII combines the intellectual and technological resources of a top-ranked public research university with experts to address major challenges in the industry.
BioCentriq is the only industry-facing contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies located on a university campus in the United States. It’s also the first facility of its kind in Newark, the state’s largest city.
The Biopharma team at NJII takes on cell and gene therapy projects from industry giants and innovative startups alike and provides customized solutions to the challenges they face. GMP clinical manufacturing is conducted in its industry-leading cleanrooms equipped with the latest manufacturing technologies. The team has more than 90 years of collective experience in manufacturing services, which makes them perfect partners for technology developers of any size. One of the things that’s unique about the center is its mission of helping the industry advance. This means BioCentriq welcomes partners that wish to gain skill and experience by working on-site collaborating with its scientists. BioCentriq’s team also works on traditional fee-for-service projects and pre-competitive development projects for companies that do not typically perform this work in-house. In all cases, the intellectual property generated at BioCentriq belongs to the client.
The New Jersey Bio Foundry, part of NJII, is a full-service startup support network that offers partnering and investment opportunities to corporate and investor partners. Utilizing NJII’s three-way partnership model promising early-stage ventures are matched with customized resources that include capital, talent, assets, and mentoring, the Bio Foundry is a one-of-a-kind platform providing viable startups and scale-ups with the unique tools they need to succeed. Members of the Bio Foundry are given access to a vast network of entrepreneurs established by NJII and partners such as the Innovation Accelerator Foundation (IAF). Building upon the IAF, which has made over 3,000 connections between high value ventures, investors, and entrepreneurs, the Bio Foundry’s network of over 33 top-tier universities in their network gives them privileged access to emerging talents and technologies. On top of a network of universities, Bio Foundry partners with BioNJ, the Healthcare Institute of New Jersey, NJEDA, Regional I-Corps™, TechUnited:NJ and many other organizations.
Rowan University, based in Glassboro, is home to the Cell & Gene Therapy Center (CGTC). CGTC was founded in 2001 as a combined clinical and basic research facility, partnering with Cooper Hospital and the former UMDNJ-School of Osteopathic Medicine (now RowanSOM). Their focus is on neurological diseases that can be treated using the latest gene transfer technologies and cell transplantation methods. CGTC is a “translational” research facility, which means that they bring discoveries from the laboratory bench directly to the clinical setting.
The CGTC aims to identify potential therapeutic avenues arising from the characterization of models of human neurological diseases. The translation of basic research into therapy requires the investigation of disease mechanisms at multiple levels, ranging from the molecular to the behavioral. Investigators at the CGTC, therefore, adopt a multidisciplinary approach to the study of diseases of the brain and employ a wide range of laboratory techniques in this process.
RowanSOM and Cooper Hospital have hosted a NIH-sponsored Phase I/II study on Gene Therapy for Canavan Disease, in collaboration with Children’s Hospital of Philadelphia and The University of North Carolina, Chapel Hill, under a major grant from the National Institute for Neurological Diseases and Stroke (NINDS). This clinical trial represented the first use of adeno-associated viral vectors (AAV) in the human brain, as well as the first viral gene therapy for a neurodegenerative disorder.
New Jersey’s graduate schools have designed master’s programs to prepare students, as well as professionals, for dynamic careers in the biopharmaceutical industry. Specifically, NJIT, in collaboration with NJII, is offering a professional science master’s degree program and professional graduate certificate in cell and gene therapy. The master’s program, the only one of its kind in the U.S. and the only cell and gene program on a college campus, provides students with an advanced study of how living organisms and biological processes can be used in technology, medicine, engineering, and agriculture to solve some of the world’s most complex challenges. In addition, NJII developed a cutting-edge apprenticeship program where select students are trained for the field of bio manufacturing over an 18-month period.
NJII is working with leading biopharma companies to lead training programs that bring both current employees and new hires to skill readiness in manufacturing and clinical procedures. NJII facilities are currently serving as a hub for joint workforce development programs in biologics and cell therapy.
Coriell Institute of Medical Research is a nonprofit research institute dedicated to improving human health through biomedical research. Coriell scientists lead research in personalized medicine, cancer biology, epigenetics, and the genomics of opioid use disorder. Coriell also hosts one of the world’s leading biobanks—comprised of collections for the National Institutes of Health, disease foundations and private clients—and distributes biological samples and offers research and biobanking services to scientists around the globe. To facilitate drug discovery and disease study, the Institute also develops and distributes collections of induced pluripotent stem cells.
Hackensack Meridian John Theurer Cancer Center is one of the few sites offering chimeric antigen receptor (CAR) T-cell therapy—a highly promising form of personalized immunotherapy for certain blood cancers—and has been involved in CAR T-cell research for nearly a decade. The FDA has approved CAR T-cell therapy for use in patients up to age 25 with acute lymphoblastic leukemia (ALL) that either recurred or stopped responding to other leukemia treatments, and to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. The treatment is under study and expected to be approved for other types of blood cancer.
Robert Wood Johnson University Hospital New Brunswick, an RWJBarnabas Health facility, in conjunction with Rutgers Cancer Institute of New Jersey, is one of only two certified programs in the state to offer CAR T-cell immunotherapy. CAR-T is being used in the treatment of particularly difficult forms of acute lymphoblastic leukemia, a type of blood cancer in children and young adults. Eligible patients have already gone through conventional therapy, which eradicates the disease in upwards of 90 percent of affected individuals. But for the 10 percent of patients who aren’t cured, this therapy could be the solution. The therapy also has been approved for the treatment of refractory diffuse large B-cell lymphoma, a dangerous variant of the most common type of non-Hodgkin lymphoma among adults. As an NCI-designated Comprehensive Cancer Center, Rutgers Cancer Institute is driving the development of next-generation CAR T-cell therapies through on-site research aimed at improving efficacy and reducing toxicity.
Bristol-Myers Squibb Company is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Their New Jersey corporate HQ is located in Lawrenceville. Building upon their transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancer patients, its researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR-T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. They are developing cancer treatments directed at key biological pathways using their protein homeostasis platform, a research capability that has been the basis of their approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Its scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress it has made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. In 2019 Bristol-Myers Squibb acquired Celgene, further strengthening its ability to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities.
Celularity, Inc., headquartered in Warren, is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies, engineered from the postpartum human placenta, in cancer immunotherapy and functional regeneration. Using proprietary technology in combination with its IMPACT™ platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative and highly scalable off-the-shelf treatments for patients with cancer, inflammatory and age-related diseases. Some of its placenta-derived allogeneic cell therapy products aim to augment immunity by harnessing a patient’s own immune system to combat disease. Its other products seek to augment longevity by targeting organ and tissue repair and functional regeneration. With this approach, its ambition is to augment human immunity and longevity, and to improve the human health span. Celularity recently announced two cell and gene therapies for the treatment of COVID-19 and Acute Respiratory Distress Syndrome (ARDS). ARDS, the most devastating complication of COVID-19, is a serious inflammatory lung injury that causes hypoxemia, or below-normal oxygen level in the blood.
In January 2020, Hitachi Chemical Advanced Therapeutics Solutions (HCATS) opened a new cell and gene therapy manufacturing facility in Allendale, New Jersey. The new facility is the company’s first to be designed from the ground up to meet the unique needs of commercial cell and gene therapy products, and it more than doubles HCATS’ existing manufacturing capacity in New Jersey. The facility currently includes six classified environment rooms with the capacity to add more rooms that can be specifically configured to accommodate growing client needs. The new facility includes state-of-the-art manufacturing development laboratories, quality control and microbiological laboratories, warehousing, executive offices and meeting space.
Novartis, with its U.S. headquarters in East Hanover, is a pioneer in cell and gene treatment and developed the first CAR-T cell therapy approved for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). This heritage includes setting the standard in patient and caregiver support, safety and efficacy, access, and partnerships with healthcare institutions, local health authorities, and academic institutions around the world. Novartis currently has three key focus areas for the development of transformative cell and gene therapies at Novartis: AAV-based therapies, CAR-T cell therapies and CRISPR-based technologies.
PTC Therapeutics was founded in New Jersey by Stu Peltz, Ph.D. in 1998 and is located in South Plainfield. PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC’s ability to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines and its mission to provide access to best-in-class treatments for patients who have an unmet medical need.
Source: HINJ, PhRMA, January 2020
Source: Genetic Engineering & Biotechnology News, September 2018
Source: Genetic Engineering & Biotechnology News, September 2019
New Jersey’s commercialization ecosystem is comprised of leading research centers, medical schools and some of the best medical centers in the nation. Our innovation ecosystem is well-suited for cell and FDA-approved gene therapy companies looking to relocate or expand their businesses.
New Jersey has the largest concentration of scientists and engineers per square mile in the U.S. and is home to over 3,200 life sciences facilities operating across all sectors.
New Jersey offers companies a growing pool of STEM talent, setting the standard for educating the next generation of visionaries. Our state’s higher education institutions turn out the 4th highest share of STEM graduates in the U.S.
Six of these research universities—including #1 ranked Princeton University and Big Ten Academic Alliance member Rutgers University—offer graduate and postgraduate degrees in biomedical and healthcare fields.
New Jersey’s workforce has experience in designing and validating process automation, producing cell drugs and products, applying QA and QC protocols and managing the supply chain and transportation logistics, among other vital duties.
Cell and gene therapy manufacturers benefit from cities and regions featuring a “cluster” of contract manufacturers because they possess expertise with multiple bioprocesses and can still learn more.
Manufacturers can utilize New Jersey’s talent pool from industries where traditional, chemical-based medicines are made, or markets where other regulated industries producing products for human consumption like cosmetics and nutraceuticals. New Jersey is home to approximately 20 cosmetic manufacturers, including L’Oréal, one of the world’s largest cosmetics companies and top beauty brands in the world.
Princeton University for the 10th consecutive year
Source: U.S. News & World Report 2020
Source: National Science Foundation: Science & Engineering Indicators 2020
Source: McKinsey, 2018
The majority of cell and gene manufacturing companies are located in the northeast U.S. New Jersey’s location puts it in the center of the long hub of cell and gene manufacturing companies along the east coast. New Jersey is located in the middle of the concentrated, affluential Boston – New York City – Philadelphia – Washington D.C. market.
The highly specialized manufacturing process required for cell and gene therapy imposes significant burdens due to the complexities associated with transporting, storing and processing raw materials and shipping finished product. The production of cell therapies requires even greater vigilance against threats that can degrade purity, potency and efficacy. New Jersey’s vast transportation system can easily expedite express deliveries to maintain the integrity of cell and gene therapies. Newark Liberty International Airport and other nearby airports offer daily non-stop flights to over 340 nonstop domestic and 260 nonstop international destinations. The State’s unrivaled road and rail network includes 2,900 miles of interstates and highways and the nation’s highest railroad density. New Jersey is also home to the Port of New York and New Jersey, the East Coast’s largest seaport, making it easy to move products across the country or around the world.
Source: Fierce Biotech, June 2020
Source: FDA, 2017
Source: PhRMA, February 2020
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