A Continuum from discovery to clinic

The popularity of lentiviral vectors in pre-clinical & clinical programs brings scientists and clinicians to use high quality lentiviral vectors from discovery to clinic. Combining Flash Therapeutics' know-how and high tech processes, Flash Therapeutics renders small, medium and large-scale production of high quality vectors available with the same attribute specifications, from R&D grade to GMP grade. 

Manufacturing dyptique

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.

Continuum steps

Each step of the way we accompany you with regular meetings to discuss milestones, project advancement, results and to define future moves.

Continuum Project Flashtherapeutics

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:
> 2 areas in B class dedicated to cell culture and expansion (2x 25m²)
> 1 area in B class for media preparation (25m²)
> 1 area in B class for fill & finish (40m²)
> 200m2 in C class dedicated to vector manufacturing, divided in 3 suites including 1 for bioreactor

> 1 storage area in C class (40m²)

> 200 m² of storage area (RT, +4°C, -80°C)

Since 2021 : 
From 45 to 200 mL* 

Starting in 2023 :
> From 45 to 500 mL*
> From 700 mL to 2000 mL* in bioreactors, dedicated to adherent cells

*Final product at 109 IG/mL, depending on crude titer