Plasmid DNA Development & Manufacturing
Industry veterans, a gold-standard facility, and pharma-level quality systems. Get your pDNA manufactured to your specifications.
Akron Bio has been a trusted GMP partner for cell and gene therapy companies since 2006, serving hundreds of today’s cutting-edge therapeutic developers. Our 110,000 Sqft state-of-the-art cGMP facility exemplifies our commitment to providing capacity, flexibility, experience, and reliability to our clients.
Our platform process is flexible by design to ensure performance with your plasmid. To ensure safety, the cGMP suite is equipped with single-use bioreactors ranging from 22L, 50L, to 200L.
Our team collaborates closely with each client to deliver phase-appropriate high-quality pDNA from 0.1g to 100g quantities.
Supporting Leading Advanced Therapy Companies in:
Plasmid DNA Offerings
| Category | Plasmid DNA Manufacturing Attributes | Research Use Only (RUO) |
GMP (DMP Clinical) |
|---|---|---|---|
| Operations | Personnel | Process Development Scientists | Manufacturing Technicians |
| Manufacturing Scale | 5 L, 30 L | 22 L, 50 L, 200 L | |
| GMP Raw Materials | CGMP grade material when available, may not be QA released | CGMP grade sourced from qualified suppliers. ID test only | |
| Environment / Facility | PD lab / Not Classified | GMP Suite / ISO 7 | |
| Equipment Qualification | PD equipment | Qualified Equipment | |
| Single-Use/Glass | Single-Use/Glasst | Single-Use | |
| Cell Bank (RCB/MCB/WCB) | RCB | MCB/WCB | |
| Critical Process Parameters | Monitored | Defined, and optimized | |
| Material Control | Fully Traceability of Materials | ||
| Full room changeover prior to each production | ✓ | ||
| Production in segregated & dedicated space | ✓ | ||
| Aseptic fill and finish | ✓ | ||
| Master Batch Records | ✓ | ||
| Environmental Monitoring | ✓ | ||
| Raw Material Testing Requirement | Use of Vendor COAS | ✓ | |
| Manufacturing Summary Report | ✓ | ||
| QC | Certificate of Testing (COT) | ✓ | |
| Certificate of Analysis (COA) | ✓ | ||
| Specifications | ✓ | ||
| QA | TSE-BSE Free Certificate | ✓ | |
| Focused QA oversight | ✓ | ||
| Full QA Oversight for production | ✓ | ||
| Full QA oversight for release | ✓ | ||
| Customized Quality Agreement | ✓ | ||
| Standard Quality Agreement | ✓ | ||
| Change Control | ✓ | ||
| Deviation, OOS control | ✓ | ||
| Batch Record QA review | ✓ | ||
| GMP Statement issued by QA | ✓ | ||
| REG | Document support for IND and IMPD filing | ✓ |
Research-Grade Plasmid DNA
High-quality research-grade plasmids for emerging biotechs & research-stage programs.
Process Development
Process development for challenging plasmids and products demanding the highest purity and yields.
cGMP Plasmid DNA
Drug substance and ancillary material cGMP plasmid production to meet Global regulatory requirements.
Facility and Quality Systems
Our cGMP facility ensures your plasmids exceed industry requirements.
Akron Plasmid Manufacturing Services Overview
