Plasmid Manufacturing
Integrated Plasmid Production to Streamline and Accelerate Vector Manufacturing
With over 20 years of experience in cell and gene therapy manufacturing, Andelyn understands how plasmids can impact vector packaging performance. Our integrated plasmid and vector approach creates a seamless transition from plasmid production 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 is based on a single-use mindset and all GMP plasmids are produced in a cleanroom.
| 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 Plasmid Center
Discover the pivotal role of the Andelyn Plasmid Center (APC) in advancing gene therapy from innovative concept to clinical reality. Located within Columbus, Ohio, our facility specializes in the production of high-quality research, toxicology, and GMP-grade plasmids. Our comprehensive services, from vector design and consulting to advanced process development, support clients at every stage of development.
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.