Frequently asked questions
Where are your pDNA development and manufacturing capabilities located?
Our pDNA development and manufacturing capabilities span our biologics sites in Waltham, MA, and Vilnius, Lithuania, as well as our gene therapy site in Vilnius. This cross-site network allows pDNA programs to access development, analytical, scale-up, and cGMP manufacturing capabilities based on program needs, while also enabling closer integration with downstream gene therapy workflows where relevant.
What applications can your pDNA support?
Our pDNA manufacturing capabilities can support a range of applications, including viral vector production, cell therapy workflows, gene therapy, mRNA manufacturing, and other advanced biopharmaceutical applications. The development and manufacturing approach can be tailored to the intended use and specific requirements of the plasmid.
Can you optimize an existing pDNA fermentation process before cGMP manufacturing?
Yes. An incoming pDNA process does not need to be manufacturing-ready. Where needed, our upstream development team can optimize fermentation conditions and other process parameters to improve plasmid yield, consistency, robustness, and scalability before transfer into cGMP manufacturing.
How do you ensure pDNA quality?
Analytical characterization and quality controls are integrated throughout pDNA development and manufacturing. We assess relevant product and process attributes to support plasmid identity, purity, quality, consistency, and control of process-related impurities throughout the manufacturing process.
Can pDNA manufacturing be integrated with other services?
Yes. pDNA can be integrated into broader development and manufacturing workflows, including viral vector and cell therapy programs. Bringing pDNA and downstream advanced therapy capabilities together within Northway Biotech can help simplify technology interfaces and create a more coordinated development and manufacturing pathway.
