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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.

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:

  1. Complete, executed, GMP-S Proposal
  2. Receipt of Purchase Order/Payment information
  3. Receipt and research grade screening of starting material (if not starting from an existing Aldevron-produced Master Cell Bank)
  4. 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.