THE CELL AND GENE THERAPY DEVELOPMENT CENTER OF NEW JERSEY
Haro Hartounian, Ph.D.
Senior Executive Director, Biotechnology and Pharmaceutical Innovation iLab
New Jersey Innovation Institute NJIT 400 Fenster Hall
323 Dr. Martin Luther King Jr. Blvd. Newark, NJ 07102
Cell therapies, both autologous and allogeneic, have tremendous promise to treat a range of diseases, including cancer, neurological disorders and diabetes. Important cell therapy clinical trials are underway for many other conditions, and researchers continue to explore new avenues using these cells in medicine (240+ unique trials have been identified from 2004 to the end of 2016).
Companies around the world are working closely with regulatory agencies to accelerate development and approval of cell and gene therapy products.
The Cell and Gene Therapy Development Center of New Jersey (CGTDC) combines state-of-the-art technologies, infrastructure, facilities and know-how to support the development and manufacturing of cell therapy products. In addition, it provides training, education and workforce development solutions for those who want to expand or gain additional training and expertise in cell and gene therapy manufacturing. Our goal is to develop our center into a hub for collaboration with industry, government and regulatory agencies, technology developers and academia in various fields of cell and gene therapy.
The development of robust and well-established processes for production of cell therapy products has become increasingly important as these therapies move from clinical trials toward commercialization and regulatory approval. Manufacturing processes have to be developed to produce consistent, reproducible and safe products. However, challenges such as cost, logistics, and regulatory and quality assurance should be addressed in order to develop a well-characterized cell therapy production process. CGTDC works closely with our partners in industry, regulatory agencies and technology developers in addressing these challenges. The center serves as a platform for developing innovative manufacturing technologies that address the challenges faced by the industry.
Sample process development activities:
- Development of innovative unit operations for tissue acquisition, cell isolation and expansion
- Application of single-use disposable unit operations and systems
- Development of innovative cell genetic modification techniques
- Formulation and cryopreservation process development
- Bioprocess modeling, control, and data analytics and management
- Analytical methods development for quality control and product consistency
Regulatory strategy development by working closely with FDA and EMA
CGTDC Workforce Development and Education
Cell therapy manufacturing is unique and is often confronted with a wide range of employee training and development challenges. The center partners with industry, regulatory agencies and academia to create workforce development solutions for cell therapy companies.
The center offers to:
- Deliver education in cell therapy manufacturing to foster innovation, and professional development in cellular therapies
- Identify critical advanced cell manufacturing skills and train entry-level workforce
- Develop customized, general and online courses to train manufacturing personnel on emerging cell manufacturing topics
- Develop industry internships (summer undergraduate internship or postdoc)
Our training services embrace a wide range of approaches, from short-term skills-building courses with specified outcomes to professional certifications.
CGTDC’s facility is designed to be a multiproduct operation employing single use product flow to allow maximum flexibility. It will offer cGMP Cell and Gene Therapy processing suites, a process development pilot plant (unit operations lab, PAT and modeling lab), training and conference rooms, and management offices.
CGTDC brings together a complete range of expertise and knowledge to develop innovative cell therapy manufacturing technologies. Our team is led by a core of professionals with more than 100 years of combined experience in process development, manufacturing, and biochemical and chemical engineering.