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DNA Vaccine & Drug Solutions

DNA Vaccine & Drug Solutions

DNA vaccines and DNA drugs are advancing the next generation of genetic medicines, offering new opportunities in infectious disease prevention, oncology, and immunotherapy. However, developers often face challenges in achieving high plasmid yields, controlling impurities, maintaining product stability, and accelerating regulatory readiness. ProBio helps overcome these barriers with an integrated DNA vaccine and DNA drug CDMO platform, combining high-yield GMP plasmid manufacturing, drug substance and drug product development, formulation optimization, fill-finish, and regulatory support from early development through commercialization.

DNA vaccines and DNA drugs use engineered plasmid DNA to express target antigens or therapeutic proteins in vivo. Compared with traditional approaches, they offer advantages such as flexible design, scalable manufacturing, and favorable safety profiles.

To support the growing demand for clinical-grade DNA products, ProBio provides a comprehensive development and manufacturing platform backed by extensive experience supporting plasmid-based programs from IND-enabling CMC through commercialization.

DNA Vaccine Solutions Manufacturing Workflow A workflow from target gene and plasmid DNA through fermentation, purification, drug substance concentration, formulation and final drug product. Target Gene DS Formulation DP Plasmid DNA High DensityFermentation Purification High Concentration ofPurified DNA Drug Product High–Yield Plasmid Manufacturing • Fermentation yield up to 3 g/L• Supercoiled ratio up to 97%• Scalable GMP production from clinical to commercial supply Integrated DS & DP Development Accelerated CMC & Regulatory Support
DNA vaccine development and manufacturing workflow Six development stages from IIT through late-stage clinical development, with manufacturing grades shown beneath each stage. IIT IND–EnablingCMC IND Filing/FDAApproval Early StageClinical Late StageClinical Late StageClinical GMPro™ Grade IND CMC GMP Grade GMP Grade BLA PC & PV GMP Grade
Flyer cover: DNA Vaccine and Drug Platform - Integrated solutions from plasmid DS/DP development to GMP manufacturing
Flyer cover: High-Yield GMP Plasmid Manufacturing - Rapid timelines and regulatory expertise for DNA vaccines

Frequently Asked Questions

Ready to accelerate your DNA vaccine or DNA drug program?

Ready to Accelerate Your DNA Vaccine or DNA Drug Program?

Connect with our team to discuss a customized path from plasmid development to commercial manufacturing.