Image Credit: ProBio Inc.
ProBio Inc, a contract development and manufacturing organization (CDMO) that is also known as GenScript ProBio, will be growing its plasmid DNA (pDNA) and viral vector manufacturing services by opening a new 128,000 square-foot plant in Hopewell, NJ.1 This new facility will operate as the hub for all North American operations, which augments the CDMO’s ability to product cell and gene therapies (CGTs) throughout the continent.
The new site features office, laboratory, and manufacturing spaces that are prepared with the latest equipment and technology for process development and current good manufacturing practice (cGMP) production of plasmid DNA and viral vectors, including lentivirus, adeno-associated virus, and retrovirus.
Beyond these capabilities, the facility provides drug product manufacturing for clinical and commercial-grade plasmid DNA, viral vector-based therapies, support for tech transfer, method and analytical development, process development, and drug substance. The company noted that all operations are held to rigorous quality control and quality assurance processes. ProBio received the 2024 CDMO Leadership Award in Compatibility, Quality, and Reliability from Industry Standard Research and Life Science Connect earlier this year, a reminder of the company’s belief in delivering therapies to the biotech and pharmaceutical industry.
“We are proud to expand our capabilities to manufacture life-changing biologic drugs to the growing cell and gene therapy industry. Our dedicated, talented team and state-of-the-art manufacturing facility here in Hopewell, NJ, will help expedite bringing these therapies to patients,” said Li Chen, ProBio’s CEO. “This expansion underscores our commitment to accelerating the delivery of advanced therapies to patients.”
Being able to welcome this Hopewell plant represents a concept that is coming to fruition; ultimately, it is one that not only helps patients who are in dire need of receiving their treatments, but helps them receive those therapies at a faster rate.
“The Hopewell facility exemplifies our mission to bring innovative therapies from concept to reality,” commented Patrick Liu, chairman of ProBio. “By enhancing our capabilities, we not only support the rapid development of novel treatments but also ensure that these therapies reach patients more efficiently and effectively.”
The facility’s cGMP suites are expected to undergo renovation to produce pDNA and viral vectors for phase-appropriate programs, enhancing the company’s capabilities and reinforcing its leading position in the biotech sector.
Back in Q1, the company reached a collaboration agreement2 for cell therapy development in Japan, in which it would provide CDMO services for preclinical development and GMP manufacturing of cell therapy products. ProBio would offer its CDMO services for various gene vectors to cell resource corporations and its clients in joint projects, including plasmids and plasmid derivatives, lentiviral vectors, retroviral vectors, and mRNA.
“The company is pleased to partner with Cell Resources Corporation and Alfresa Holdings Corporation, to offer a comprehensive solution for patients from vectors to cell therapy products,” expressed Li. “This collaboration will speed up the advancement of cell therapy and facilitate the seamless production of qualified and affordable cell therapy products for treating patients, both in Japan and worldwide.”
References
1. ProBio Expands Plasmid DNA and Viral Vector Production in New Jersey to Accelerate Delivery of Life-Changing Cell and Gene Therapies. PR Newswire. June 25, 2024. Accessed June 25, 2024. https://www.prnewswire.com/news-releases/probio-expands-plasmid-dna-and-viral-vector-production-in-new-jersey-to-accelerate-delivery-of-life-changing-cell-and-gene-therapies-302181104.html#:~:text=HOPEWELL%2C%20N.J.%2C%20June%2025%2C,facility%20in%20Hopewell%2C%20New%20Jersey.
2. GenScript ProBio Signs Collaboration Agreement with Cell Resources Corporation, a Subsidiary of Alfresa Holdings Corporation for Cell Therapy Development. GenScript ProBio. February 1, 2024. Accessed June 25, 2024. https://genscriptprobio.com/genscript-probio-cell-therapy-development.html