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

Aldevron retains process control

 

Controlled, non-classified suites

 

QA sampling review of documentation

 

Manufacturing summary report

 

Segregation

Documentation

Traceability

Vendor Management

CAPA

Master Batch records dictate process

 

ISO-classified suites & EM

 

QA review of all documentation

 

Change control

 

Validation

 

GMP-Source®(GMP-S)

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.

ALD-GMP-Source-1

Accompanied by a comprehensive manufacturing summary report suitable for regulatory submissions, we deliver high-quality products to fit your GMP-S project.

cGMP

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.

ALD-cGMP-1

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

Assay

Method

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

Drug Substance

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

*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.

Asset 1@4x-1

GMP-Source® and cGMP Offerings

ALD-Platform-Quality_Plasmid-DNA-source-cGMP

Plasmid DNA


ALD-Platform-Quality_Protein-source-cGMP

Protein


ALD-Platform-Quality_mRNA-source-cGMP

mRNA