GMP and non-GMP plasmid production for pre-clinical, clinical and commercial applications
GMP plasmid production
NorthX Biologics is dedicated to providing GMP grade plasmid DNA for clinical and commercial applications. Our plasmid manufacturing meets full Good Manufacturing Practice (GMP) standards in qualified clean rooms, ensuring the highest level of quality and safety for use in applications such as DNA vaccines, direct-delivered gene therapy, and late-phase viral vector products.
- Fully single-use process equipment
- Fully traceable non-animal origin raw materials
- RNase-free process
- Drug substance quality
- GMP level analytics and certificate of analysis (CoA)
- EU release via on-site qualified person (QP)
- Clinical and commercial scale
High quality plasmid production
NorthX Biologics offers high quality grade plasmid DNA for pre-clinical applications in vitro or in vivo, including toxicology studies. Our high quality plasmid DNA is manufactured in accordance with regulatory expectations for critical starting material for cell and gene therapies, making it suitable for the production of viral vectors for clinical use. By utilizing our defined platform technology, we provide a fast turnaround from the start to the delivery of the plasmid.
- Critical starting material for cell and gene therapies
- mRNA Templates
- Aligned high quality level analytics
- Segregated laboratories
Plasmid DNA solutions for all phases
We offer a range of plasmid qualities with the right level of control for every purpose, ensuring efficient expedition of your program with full regulatory compliance.
Research Grade 2-4 weeks
- For discovery and pre-clinical development
- Single use or reusable equipment
- Cost effective and fast turnaround
- Flexible analytival panel
High Quality Grade 5-6 weeks
- Critical starting material for CGT applications
- Segregated laboratories
- Analytics aligned with GMP
- Fully single use process
- Traceable non animal origin raw materials
- TSE/BSE certification
- CoA
GMP Grade 8-12 Weeks
- Drug substance applications; pDNA vaccines, direct GTs, late stage critical starting material
- Fully single use process
- Traceable non animal origin raw materials
- Phase appropriate validation if analytical methods
- TSE/BSE certification
- CoA
- QP release and certification
