ProBio, a global contract development and manufacturing organization (CDMO), has officially opened its Plasmid & Viral Vector Center of Excellence in Hopewell, New Jersey, marking a significant expansion in North American gene therapy manufacturing capabilities. The purpose-built, 128,000-square-foot GMP facility is designed to accelerate high-quality plasmid and viral vector manufacturing to support the next generation of advanced therapies.
Accelerated Manufacturing Timelines
The new facility delivers clinical-grade plasmid DNA production from cell bank to batch release in three months, addressing a critical bottleneck in gene and cell therapy development. ProBio's integrated approach includes process development, in-house analytical testing, method development, and project management, minimizing the need for multiple suppliers and accelerating development timelines.
The company's new capabilities ensure plasmid DNA with greater than or equal to 85% supercoiled plasmid DNA content while reducing contamination risks. GMP-like plasmids are delivered in four weeks, while GMP-grade plasmids are available in three months, significantly reducing time to clinic.
"We understand pharmaceutical companies' concerns about how many plasmid DNA manufacturers do not have predictable timelines and we are committed to raising the bar for the industry and we will deliver at the speed drug developers deserve," said Allen Guo, CEO of ProBio.
Strategic Location and Economic Impact
Located on the former Bristol Myers Squibb R&D and manufacturing campus, the Hopewell facility serves as the hub for ProBio's North American operations. The site is strategically positioned to serve both U.S. and European markets, enhancing the company's capability to support manufacturing of life-changing cell and gene therapies in North America.
The facility will support more than 100 high-paying jobs across various roles including process development, GMP manufacturing, quality control, supply chain, and engineering. John Coelho, senior advisor at the New Jersey Economic Development Authority (NJEDA), noted that the site contributes to the state's goal of becoming a global hub for advanced biomanufacturing.
"This site enhances the ability to attract, retain and grow biotech innovation, especially in the fast-growing field of gene modified cell therapies," Coelho said. "In fact, more than 40% of cell and gene therapies are manufactured in [New Jersey]."
Future Expansion Plans
ProBio plans significant capability expansions at the Hopewell facility. The company's cGMP AAV manufacturing capabilities are expected to launch by Q3 2025, followed by cGMP LVV capabilities in Q1 2026, further expanding the company's integrated service offerings.
As a global partner with locations in China, Japan, Europe, and Korea, ProBio integrates multidisciplinary expertise to expedite the production of advanced treatments, including biologics, mRNA and protein vaccines, viral vectors, antibody-drug conjugates, and drug discovery services.
Patient-Centered Mission
The facility's opening ceremony featured a keynote address from Donavan Decker, who in 1999 became the first person in the world to undergo gene therapy for any form of Muscular Dystrophy. The groundbreaking procedure, led by Dr. Jerry Mendell at The Ohio State University Hospital, laid the foundation for future advancements in genetic medicine.
Decker, who was honored with the Muscular Dystrophy Association (MDA) Legacy Award for community impact in research in 2025, has helped guide research priorities to reflect patient needs and improve patient care through his service on various advisory boards.
"This is not just a new facility. It is a beacon of hope for patients waiting for cures," said Guo, emphasizing the facility's role in advancing treatments for debilitating and otherwise incurable genetic and rare diseases.
