GMP lentiviral particle manufacturing for clinical applications
Manufacturing platform for phase I/II clinical trial
Through its lentiviral manufacturing platform, Flash Therapeutics provides medium scale GMP lentiviral vector batches for phase I/II clinical trials. Those batches are manufactured by the Flash Therapeutics' team at Saint-Louis Hospital (Public Assistance Hospital of Paris AP-HP) at the new cell and tissue engineering facility, the MEARY center. Combining Flash Therapeutics' know-how (lentiviral vector manufacturing since 2005) and high tech equipment, Flash Therapeutics provides high quality GMP grade vectors for clinical gene therapy programs.
A fully integrated & flexible manufacturing offer
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.
Flash Therapeutics provides its starting material including high quality grade 3rd generation packaging plasmids and the master cell bank. Otherwise, we can use your starting materials if needed.
Step by step qualification plan
The different stages of each GMP project are performed in close cooperation with our customers. They include:
1. Development and qualification
- Plasmid sequence validation
- Crude vector production
- Small scale vector production
- Large scale vector production
2. GMP grade vector manufacturing
- Non GMP pilot batch production
- GMP batch production
3. Quality control
- GMP vector quality controls
Benefits of our lentiviral vector manufacturing platform
QUALITYPure & highly concentrated particles
SCALABILITYFrom small to large scale production
REPRODUCIBILITYReproducible volumes from 1 to 60 ml
SUPPLY CHAINFrom plasmid supply to vector QCs
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.
Manufacturing platform for clinical phase III and commercial products
In order to provide large scale GMP lentiviral vector batches, Flash Therapeutics is building its own GMP facility in Toulouse, which will be fully operational in 2020.