GMP Plasmid DNA Manufacturing
GMP Plasmid DNA
Driven by a comprehensive quality assurance process, we produce GMP plasmid DNA in segregated ISO-classified manufacturing suites ensuring the highest quality products with each and every order. Combined with dedicated project management and client-specific batch records, we work closely with our clients to provide customized GMP plasmid products.
Our full GMP fermentation capacity ranges from 10 to 1,000 liters. This allows us to offer a complete spectrum of plasmid DNA services, spanning from early research to commercial supply.
- Screening for Optimal Growth
- E. coli Master and Working Cell Bank Generation
- Development and Engineering
- Shake Flask or High-Density Fermentation
- Alkaline Lysis
- Chromatographic Purification
- Quality Oversight and Process Control
- Manufacturing Summary Report, TSE/BSE Statement
- Client-Specific Master Batch Records
In addition to the assays below, we can provide custom developed procedures to meet your requirements.
| 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 |
In addition to the assays below, we can provide custom developed procedures to meet your requirements.
| 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 |