cGMP lentiviral particle manufacturing facilities to produce gene and cell therapy drugs
A GMP facility for small scale GMP grade lentiviral batches fully operational in 2019 through a three-year partnership between Flash Therapeutics and Saint-Louis Hospital:
Flexible innovative GMP offer: a continuum from R&D to clinic
Flash Therapeutics offers high level expertise to develop, conduct and validate custom studies, optimize and scale-up manufacturing projects. Our CDMO activity is conducted on a customized basis according to your starting material.
You can provide us with your GMP grade plasmids already amplified or your master cell bank. We can also use our starting material. We will take in charge your GMP production following the maturity of your project:
Step by step qualification plan
The validation stages of a cGMP compliant production project are done step by step in close cooperation with our customers. The validation phases include:
- Plasmid sequence validation
- Crude vector production
- Small scale vector production
- Large scale vector production
- Non GMP pilot batch production
- Transfer in GMP facility
- cGMP batch production
- cGMP Vectors quality controls (available under request)
A premium production process for premium vector quality
The investment in manufacturing started early in our development, since we consider that providing high-class quality, is a success factor for the development of disease models and gene therapy. Even if manufacturing processes differ for the different vectors used in gene therapy, a common requirement is an efficient purification of the product to remove any contaminating viral components that can have a detrimental effect on target cells (cell proliferation, cell differentiation capability, senescence, etc.).
Through a patented process, involving serum and antibiotic free media and followed by several purification steps, we obtained the removal of 99% of proteins and DNA impurities. These purification steps avoid phenotype changes or specific cell responses following transduction. Our lentiviral manufacturing platform provides the highest purity on the market. In parallel, we have developed a reliable and discriminating titration method that guarantees robust and reproducible performances of vector batches.
Future in-house GMP facility for 2020
In order to provide large scale GMP lentiviral vectors, Flash Therapeutics is building its own GMP facility in Toulouse, which will be fully operational in 2020: