GMP Manufacturing offer for lentiviral vectors

While supplying high quality vectors for research and preclinical purposes, Flash Therapeutics’ has now launched its cGMP compliant lentiviral vectors production platform for clinical applications.

Manufacturing dyptique

Our cGMP lentiviral vectors 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.

You can either provide us with your HQ/GMP grade plasmids already amplified or we can also use our starting material.
We will take in charge your GMP production following the maturity of your project:

manufacturing offer project

To date, we produce vectors to be used as starting material for clinical phases I/II. In 2022 we will be increasing our production capacities allowing us to produce starting material vectors for phases II and up.

Stages of cGMP compliant production

Three incremental lentivector batches are produced and delivered to you to fit to all the stages of a cGMP compliant process :
Demo batch, an Engineering batch, and your final GMP batch.

Preclinical and clinical manufacturing

Flash Therapeutics provides robust and phase-dedicated documents for all the manufactured batches of your GMP process.  

  • Facilities: management of physical parameters (air particles, temperature, humidity, pressure), environmental controls
  • Devices qualifications (QI, QO, QP)
  • Human Resources: Process validation through MPT (open and closed phases) and individual validation through MFT (process developed with bacteria media instead of all raw materials)
  • Raw materials: certificates of analysis, audit of providers
  • SOP / MOP: managed by the QMS

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 can include:

  • Plasmid sequence validation
  • Crude vector production
  • Small scale vector production
  • Medium scale vector production
  • Engineering batch production
  • Transfer to GMP facility
  • cGMP batch production
  • cGMP quality controls.

A customized Quality Control plan to fit reglementary requirements of your project

Example of QCs that can be requested:

  Standard QCs Specific QCs
P24 Elisa physical particles titer (pp/mL) x x
qPCR infectious titer (IG/mL) x x
Infectivity (IG/ngP24) x x
Mycoplasma detection x x
Expression of the genetic insert product (TEA)   x
Identity   x
pH, osmolality   x
Adventitious agents detection   x
RCL detection   x
Residual DNA   x
Residual BSA   x
Residual benzonase   x
Endotoxins   x
Sterility   x
Others: to be discussed -   x



Production site

A GMP facility for small scale GMP grade lentiviral batches fully operational since 2019 through a three-year partnership between Flash Therapeutics and Saint-Louis Hospital in Paris.

Flash Therapeutics’ own GMP facility in Toulouse fully operational in 2022:

Flash Therapeutics building