cGMP-Source® Plasmid DNA
GMP-Source® Plasmid DNA
A faster, cost-effective alternative to GMP production, GMP-Source® (GMP-S) plasmid DNA can be manufactured to standard or customizable specifications. Adopting the most relevant features of cGMP manufacturing, including traceability, document control and materials segregation, GMP-Source plasmid DNA can be used as an ancillary or critical raw material for producing protein and viral candidates used in clinical trials.
Accompanied by a comprehensive manufacturing summary report suitable for regulatory submissions, we deliver high-quality products to fit your GMP-Source project.
- E. coli Master Cell Bank Generation
- Shake Flask or High-Density Fermentation
- Alkaline Lysis
- Chromatographic Purification
- Quality Oversight
- Manufacturing Summary Report, TSE/BSE Statement
| Assay | Method |
| Final Product Appearance Testing | Visual Testing |
| Host Cell Identity | Bacterial Colony Morphology |
| Lytic Phage Contamination | Plate bacterial cells on media containing no antibiotics |
| Host Cell Identity | Gram Stain Analysis |
| Antibiotic Resistance | CFU isolation on multiple antibiotic and antibiotic-free plates |
| DNA Homogeneity | Densitometry analysis of EtBr stained AGE |
| Identity | EtBr stained agarose gel electrophoresis |
| Restriction Digest | EtBr stained agarose gel electrophoresis |
| Plasmid Identity | Double Stranded Primer Walking Sequencing. |
| Cell Bank Viability | CFU/mL plate count analysis |
| Host Cell Purity | Trypticase Soy Agar (TSA) and Sabouraud Dextrose Agar (SDA) |
| Detection of Lysogenic Bacteriophage | Plated in the presence of Mitomycin C |
| Plasmid Retention | Antibiotic Typing |
| Assay | Method |
| ABS 260/280 Ratio Purity | UV Spectrophotometry |
| Appearance | Visual inspection |
| Concentration | UV Spectrophotometry |
| DNA Homogeneity | Densitometry analysis of EtBr stained AGE |
| Endotoxin | Kinetic Chromogenic LAL |
| Identity | EtBr stained agarose gel electrophoresis |
| Plasmid Identity | Double Stranded Primer Walking Sequencing |
| Residual Host Genomic DNA | Quantitative PCR |
| Residual Host Protein | Micro BCA |
| Residual Host RNA | SYBR Gold stained agarose gel electrophoresis |
| Restriction Digest | EtBr stained agarose gel electrophoresis |
| Sterility | USP <71> Direct Inoculation |
|
Sterility Validation (Bacteriostasis/ Fungistasis) |
USP <71> Direct Inoculation |
| Mycoplasma Contamination | Quantitative PCR |
| Osmolality | USP <785> |
| pH | USP <791> |
| Bioburden | Testing for total aerobes, anaerobes, sporeformers and fungi |
| Conductivity | Conductivity Meter |
| Detection of Kanamycin | ELISA |
Aldevron employs a predictable and streamlined entry for our GMP-S manufacturing process. In this system, we require the items listed below to be completed prior to project initiation, to ensure accurate scheduling is completed. These include:
- Complete, executed, GMP-S Proposal
- Receipt of Purchase Order/Payment information
- Receipt and research grade screening of starting material (if not starting from an existing Aldevron-produced Master Cell Bank)
- Full execution of Aldevron Manufacturing Specification forms
Once these items have been received or completed, our team will provide target completion timeframes so you can better manage your process.