ProBio Sets New Standard in GMP Plasmid DNA Manufacturing with Guaranteed ≥ 85% Supercoiled DNA, Fixed-Cost, Clinical-Grade Delivered in Just 3 Months

Associated Press

09-04-2025

Hopewell-based team delivers on ProBio's promise of speed, quality, and reliability—offering a transparent, fixed-cost model and ≥85% supercoiled plasmid DNA in record time for clinical programs.
HOPEWELL, N.J., April 9, 2025 /PRNewswire/ -- ProBio, a global contract development and manufacturing organization (CDMO), is pleased to announce the launch of its GMP Plasmid DNA manufacturing service at its state-of-the-art facility in Hopewell. This new service guarantees the delivery of clinical-grade plasmid DNA production from cell bank to batch release in just three months. This is a significantly faster manufacturing time than is typical and can help accelerate the development of gene and cell therapies.
'At ProBio, our mission is to redefine reliability and innovation for biopharma partners' said Allen Guo, CEO of ProBio . '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. Our commitment is to provide therapy developers with the confidence and consistency needed to advance their breakthroughs.'
Key Advantages of Hopewell's Plasmid DNA Services:
Faster Timelines to Clinic: ProBio delivers GMP-like plasmids as little as 4 weeks and GMP-grade plasmids as fast as 3 months, reducing time to clinic accelerating development timelines.
Guaranteed Delivery (On-Time, On-Spec): ProBio guarantees that each plasmid, whether in small batches (50–200 mg) or gram-level production, meets developers' exact specifications. With full transparency and no hidden costs, ProBio provides consistent, accurate deliveries on time and on-spec.
Consistently High Quality: Leveraging reliable U.S.-based sourcing, advanced single-use technologies, and rigorous quality controls, ProBio provides a dependable solution that reduces contamination risks while ensuring consistent, high-quality plasmid DNA with greater than or equal to 85% supercoiled plasmid DNA content.
Ben Chen, Chief Quality Officer at ProBio , added: 'Our approach to quality is deliberate and built into every step of our operations. We've implemented industry best practices and phase-specific quality controls, including in-house testing, stability studies, environmental monitoring, and customizable quality packages – whether standardized or customized. Backed by comprehensive documentation systems and regulatory alignment, this ensures we deliver high-quality plasmid DNA our clients can trust—on time and on spec.'
The Hopewell facility, which has a rich legacy of biologics innovation, previously served as a research hub for a leading global pharmaceutical company and later as an AAV-based gene therapy manufacturing center. Now the centerpiece of ProBio's operations, the site is led by a team of industry veterans with decades of experience in biologics and cell and gene therapies. By combining this expertise with ProBio's proprietary platform technologies, the company ensures fast, high-quality, and consistently reliable integrated end-to-end capabilities—from plasmid DNA production to drug product fill and finish.
Strategically located to serve both the U.S. and European markets, the Hopewell facility offers a seamless, fully integrated approach to manufacturing. ProBio's expertise in process development, in-house analytical testing, method development, and project management team, minimizes the need for multiple suppliers, significantly accelerating development timelines.
Michael Vreeland, Site Head at the Hopewell facility , emphasized the company's commitment to efficiency: 'By bringing both plasmid DNA and eventually, viral vector manufacturing under one roof, we eliminate unnecessary delays and simplify the manufacturing process for our clients. Every operation at ProBio is carefully designed to address the challenges therapy developers face, ensuring smooth progress toward their goals.'
ProBio's cGMP Plasmid DNA manufacturing service represents a significantly advancement in the biopharma sector, delivering faster, more reliable, and higher-quality therapeutic development.
ProBio'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.
ABOUT PROBIO
ProBio is a global leader in advancing the development and manufacturing of next generation biologics and advanced therapies for the biotech and pharmaceutical industries. As a fully integrated end-to-end Contract Development and Manufacturing Organization (CDMO), ProBio partners with its clients to optimize drug development, accelerate time-to-market, and provide comprehensive life-cycle support.
Through a collaborative, risk-sharing approach, ProBio offers flexible licensing and co-development options for new therapeutics, enabling partners to effectively navigate the complexities of human disease with adaptable, cutting-edge therapeutic approaches.
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