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.
*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
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.
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.
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.
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.
"Without GMP-Source, there are programs that may not have gotten off the ground because they wouldn't have been able to get the funding for GMP or met timelines. Dozens of programs have progressed through the clinic that began their life through a GMP-Source project."
CSO Biotech Organization
