GMP Plasmid Manufacturing Services
Integrated Plasmid Production to Streamline and Accelerate Viral Vector Manufacturing
With over 20 years of experience in cell and gene therapy manufacturing, Andelyn understands how plasmid DNA manufacturing impacts viral vector packaging performance. Our integrated plasmid and vector approach creates a seamless transition from the plasmid production process through vector development all the way into commercial manufacturing with dedicated program management across the entire process.
Under one MSA, this integrated approach creates a seamless transition from plasmid production through vector development all the way into commercial manufacturing with integrated program management for plasmid and vector.
A Commitment to Quality at Every Stage of Your Program
Andelyn offers a spectrum of plasmid DNA grades tailored to support your project at every stage. Our unique approach to quality control is based on a single-use mindset, and all GMP plasmid DNA products are manufactured in a cleanroom environment.
We prioritize high-quality plasmid DNA to ensure consistency and compliance with clinical development and good manufacturing practices (GMP) manufacturing standards.
| Research | Tox | GMP | |
|---|---|---|---|
| Applications | In vitro R&D, PC studies | Toxicology studies | Clinical, Commercial |
| Scale | Flask | Flask / 50L Fermenter | Flask / 50L Fermenter |
| Testing Panel | Reduced | Extended | Extended |
| Cloning |  | | |
| Yield Assessment / DOE | | | |
| CoA | | | |
| E. coli MCB Production | | | |
| Plasmid Stability (Upon Request) | | | |
| Single-use disposable | | | |
| TSE/BSE statement | | | |
| Manufactured in clean room | | ||
| QA oversight | |
Customized Testing Strategy to Meet Specific Program Requirements
| Source | Research | Tox | GMP | |
|---|---|---|---|---|
| DNA Homogeneity | In-house | | | |
| Identity | In-house | | | |
| Purity | In-house | | | |
| Restriction Digest | In-house | | | |
| Concentration | In-house | | | |
| Identity (DNA) | In-house / NCH IGM | | | |
| Endotoxin | In-house | | | |
| Residual Host Protein | In-house | | ||
| Residual Host Genomic DNA | In-house | | ||
| Residual Host RNA | In-house | | ||
| pH | In-house | | ||
| Mycoplasma | In-house | |
Andelyn Development Center
Explore the Andelyn Development Center (ADC), where expert and precision-based process development, preclinical manufacturing, and analytical capabilities converge for plasmids and viral vectors. As the cornerstone of Andelyn’s rich experience in gene and cell therapy, the ADC is at the heart of our innovation and where we meet the evolving demands of our client programs.
Andelyn Corporate Center
Step inside the Andelyn Corporate Center (ACC), our clinical and commercial production facility built for the rigors of cell and gene therapy manufacturing. With the latest advances in construction and clean room technologies and GMP compliance enabling design and operations, the ACC is currently producing GMP and commercial-grade, high-quality plasmids and viral vectors. Discover how our facility reliably advances the path to market for life-saving therapies.
In-House Plasmid Production Means Secure Supply Chains
Working closely with a CDMO that performs in-house plasmid production affords companies the opportunity to collaborate and optimize processes and create efficiencies.