GMP-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.