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.
Product Details
- E. coli Master Cell Bank Generation
- Shake Flask or High-Density Fermentation
- Alkaline Lysis
- Chromatographic Purification
- Quality Oversight
- Manufacturing Summary Report, TSE/BSE Statement
Cell Bank Quality Control Assays
|
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 |
Plasmid DNA Quality Control Assays
|
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 |
Requesting a GMP-Source Project
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.
