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:

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.