ProBio, a global CDMO, has launched a GMP Plasmid DNA manufacturing service at its facility in Hopewell, NJ. 

This new service delivers clinical-grade plasmid DNA production from cell bank to batch release in three months. This can help accelerate the development of gene and cell therapies.

Located to serve both the U.S. and European markets, the Hopewell facility offers an integrated approach to manufacturing. ProBio’s process development, in-house analytical testing, method development, and project management team minimize the need for multiple suppliers, accelerating development timelines.

New capabilities allow ProBio to provide solutions that reduce contamination risks while ensuring plasmid DNA with greater than or equal to 85% supercoiled plasmid DNA content. GMP-like plasmids are delivered in four weeks and GMP-grade plasmids are delivered in three months, reducing time to clinic and accelerating development timelines.

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.

Allen Guo, CEO of ProBio said, “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.”