A tailor-made continuum from discovery to therapy
In gene therapy development, assays are often performed on immortalized cells and further translated to primary cells and tissues before in vivo experiments take place. All these assays consume a large quantity of vectors.
Flash Therapeutics proposes a continuum designed to coincide with your product development and regulatory requirements.
Thanks to our patented production and purification process that remains exactly the same for both R&D-grade and GMP-grade lentiviral vectors, we guarantee the same high quality vectors from your discovery phase to your clinical phase, thereby ensuring the success of your clinical study.
Each step of the way we accompany you with regular meetings to discuss milestones, project advancement, results and to define future moves.
A dedicated team implicated at all steps of manufacturing platform
Our working organization implies a shared view of the manufacturing process by all teams, including those dedicated to R&D / innovation, process development and analytical development, allowing everyone to understand and contribute to a synergistic workflow.
Production Capacities adapted to the scale-up of volumes and quantities
Through its lentiviral manufacturing platform, Flash Therapeutics currently provides small scale GMP lentiviral vector batches for phase I/II clinical trials. In order to provide medium and large scale GMP lentiviral vector batches, Flash Therapeutics has increased its GMP production capacities.
|Production capacities||Batch size|
|R&D grade manufacturing||
1000 m² divided into:
> 1 area for quality control activities (BSL2, BSL1, qPCR...) (165m²)
> 4 clean rooms dedicated to cell culture, QCs and cell line development (100m²)
> 3 clean rooms dedicated to vector manufacturing including process development using bioreactor (170m²)
> storage areas (RT, +4°C, -80°C, -150°C) (300m²)
Small scale batch volumes from 1 to 5 mL*
Large scale batch volumes from 10 to 60 mL*
|GMP grade manufacturing||
650 m² of cleanroom divided into:
> 1 storage area in C class (40m²)
> 200 m² of storage area (RT, +4°C, -80°C)
Since 2021 :
Starting in 2023 :
*Final product at 109 IG/mL, depending on crude titer