GMP-Source® and cGMP

GMP-Source®(GMP-S) and cGMP

Aldevron offers two different services for biologics that require additional quality and documentation, such as when your materials are destined for clinical trial or commercial product.

ALD Customer Journey copy

*The service levels outlined above are a visual representation of possible client selections. Aldevron does not recommend service levels.

GMP-Source® (GMP-S) is a cost effective alternative to cGMP. Our cGMP service provides the highest quality oversight, process control, and can support any application, including parenteral administration.

  GMP-Source® cGMP

Screening for optimal growth conditions

Growth via shake flask or high-density fermentation

Alkaline lysis

Chromatographic purification

Consistent manufacturing process

Certificate of Analysis (CoA)

E. coli master cell bank generation

Manufacturing summary report

TSE/BSE statement

Master Batch Records dictate process


ISO classified fill/finish with environmental monitoring

QA oversight

Development/engineering work prior to banking and growth


Prescriptive change control process


Project specific master batch records


ISO classified production suites


*Batch record process controlled by Aldevron


A faster, cost-effective alternative to cGMP production, GMP-Source® (GMP-S) can be manufactured to standard or customizable specifications. Adopting the most relevant features of cGMP manufacturing, including traceability, document control and materials segregation, GMP-S 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-S project.


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.

Quality Control Assays

Cell Bank



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


EtBr stained agarose gel electrophoresis

Restriction Digest

EtBr stained agarose gel electrophoresis

Plasmid Identity

Double Stranded Primer Walking Sequencing

Drug Substance



ABS 260/280 Ratio Purity

UV Spectrophotometry


Visual inspection


UV Spectrophotometry

DNA Homogeneity

Densitometry analysis of EtBr stained AGE


Kinetic Chromogenic LAL


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


USP <71> Direct Inoculation

*rProtein and mRNA are subject to further assay customization.

Ready to get started?

Start to finish, Aldevron team members show their commitment to the success of our clients through consistency of product, flexibility to your needs and schedules, and true cognitive empathy about the demands of the biotech world. As our industry expands at an almost exponential rate, we remain at your service.

In an effort to ensure we deliver the highest quality, fundamental biologics you need; we have added an efficient and easy process for clients to enter our business lifecycle. By adding a robust front-end business process, we activate a quick-to-manufacture workflow, ensuring the project starts properly and ends successfully.

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GMP-Source® and cGMP Offerings


Plasmid DNA