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A Cell and Gene Therapy Development Center Designed to Meet Your Needs

Introduction

NJII’s Cell and Gene Therapy Development Center (CGTDC) enables you to access and utilize state-of-the-art equipment to develop cutting-edge products in a cost- and time-effective manner. In the accelerating race to improve products and gain FDA
approval, your company can greatly benefit from an industry-agnostic platform that offers a variety of resources and services. You’ll also be able to collaborate with others in the competitive and burgeoning field of cell and gene therapy.

Cell Therapy

The Cell Therapy Unit has two cGMP Suites and combined Process Development and QC labs. The GMP suites are designed to process up to three patients’ cell therapy in each of Lab A and Lab B simultaneously. All processing is for the same “product” within any lab — i.e., Lab A can process three different patient’s cells simultaneously for product A (e.g., CD19 CART) while Lab B can process three different patients’ cells simultaneously for either product A or product B (e.g., BCMA CART), but within any given lab only product A or product B, not both.

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Gene Therapy (Viral Vector)

In recent years, numerous companies have entered clinical trials with viral vector vaccines. However, several challenges continue to exist, including capacity issues related to plasmid and virus production, virus stability, toxicity of the virus to the host cell lines, and limited ability to properly characterize the active virus product. These challenges have impacted consistent supply and product quality.

NJII’s Gene Therapy Unit addresses several hurdles in viral vector manufacturing, including production challenges related to the use of adherent host cell lines, virus stability, and limitations in virus characterization, as well as a lack of appropriate sensors and models to enable closed-loop control and optimization of virus manufacturing processes.

Our Facility is Designed to Meet the Highest Standards for Efficiency and Felxibility

Process Development

The Cell and Gene Therapy Development Center is here to help you augment your in-house process development capacities so you can bring a greater number of projects from preclinical to human trials without risking capital investment or the need to hire  additional employees.

Technology and Application Development

Technology and application developers will find the capacity they require at CGTDC. The Center is a collaborative facility where technology developers, process developers and members of the biopharmaceutical industry work side by side to address the challenges in cell and gene therapy manufacturing. It can serve as the platform where your new technologies can engage and impress end users. In addition, you can showcase cutting-edge equipment, conduct alpha-testing and beta-testing, and explore new opportunities for applications that can lead to marketing success.

Clinical Production

CGTDC offers two GMP suites to provide you with the capability of running your clinical trials without having to take the financial risk and extended timeline to build a new facility from square one. The Center is equipped with automated cell manufacturing stations, QC and analytical test centers as well as process development laboratories. Compared to major competitors in the industry, CGTDC features cost efficiency, high flexibility and is supported by technical expertise from collaboration partners and academia.

Helping You Build a Skilled Workforce

 

Workforce Development

We understand your need for manufacturing and QC employees to fill the skill gaps associated with this rapidly evolving technology. We have already worked with leading biopharma companies to conduct 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. NJII will work with your training team to develop a classroom-based curriculum to serve your company’s needs. In addition to offering standard courses in equipment operation, we can develop customized programs to meet your specific training requirements. Our classes are led by experienced and passionate instructors who are knowledgeable in the quickly expanding cell and gene therapy field. Thanks to our collaboration with industry technology leaders, our classes are well supported with laboratories that provide trainees with firsthand access to state-of-the-art equipment.

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Our Team

The Cell and Gene Therapy Development Center is led by Dr. Haro Hartounian who brings more than 25 years of experience and leadership developing biopharmaceutical products. He is joined by a team of engineers and scientists dedicated to addressing your manufacturing challenges and advancing your process and product development.

Contact Us

Cell and Gene Therapy Development Center
Haro Hartounian, Ph.D.
New Jersey Innovation Institute
NJIT 400 Fenster Hall
323 Dr. Martin Luther King Jr. Blvd.
Newark, NJ 07102
973.596.5810
haro.hartounian@njii.com
njii.com