cGMP
There is no substitute for experience
Congratulations! Your project is moving beyond early-phase trials. As you prepare to dose more patients, full cGMP manufacturing is required. When your materials are destined for clinical trial or commercial product, Aldevron’s cGMP services provide the highest quality oversight, process control, and can support any application.
Having supported many of our clients through clinical trials and regulatory filings. Aldevron has benefitted from years of health authority feedback, allowing us to navigate areas with limited guidance or regulation. That experience informs our clients’ regulatory strategies to help smooth the transition from pre-clinical through commercial applications.
Small-Scale and Traditional cGMP
Driven by a comprehensive quality assurance process, we produce cGMP products in segregated ISO-classified manufacturing suites, ensuring the highest quality products. Combined with dedicated project management and client-specific batch records, we work closely with our clients to provide customized cGMP plasmid products.
Our Small-Scale cGMP Plasmid service is the right-sized process for clients who need ≤500mg for early-phase clinical trials while allowing the flexibility of transition into our traditional cGMP plasmid DNA manufacturing services for larger or pivotal trials.
cGMP manufactured products offer:
- 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 (controlled by Aldevron)
- 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
Our full cGMP fermentation capacity ranges from 10-liter to multiple 300-liter runs. This allows us to offer a complete spectrum of cGMP services, from early research to commercial supply.
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 client success through consistency of product, flexibility to meet 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.
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.
