An agreement between Novasep and Theravectys gives the French CDMO access to the Institut Pasteur’s DNA FLAP technology to produce GMP-grade lentiviral vectors for clinical.

The DNA Flap tech allows efficient lentivector-mediated gene transfer either ex vivo or in vitro. It consists of a specific DNA sequence derived from the lentiviral genome, which includes the cPPT and CTS cis-active sequences, required to enable the import of the lentivirus genome into the cell nucleus of non-replicating cells.

Theravectys holds a license from the Institut Pasteur covering the production of lentiviral vectors, but contract development and manufacturing organization (CDMO) Novasep has inked a deal with the biotech firm to use the platform for its customers’ gene therapy, cell therapy, immunotherapy and vaccination projects.

Novasep in Belgium. Image: Googlemaps

“The recently signed licence agreement between Novasep and Theravectys, a spin-off biotech company of the Institut Pasteur, gives Novasep the freedom to use Institut Pasteur’s DNA FLAP technology to produce GMP-grade lentiviral vectors for clinical use in all therapeutic applications,” Jean Bléhaut, president of Novasep’s Manufacturing Solutions Business Unit, told this publication.

“The DNA FLAP sequence is required to enable the import of the lentivirus genome into the cell nucleus of non-replicating cells. Thus, DNA FLAP is essential to allow efficient lentivector-mediated transfer of therapeutic genes into non-replicating cells.”

The license allows any customer that is not a licensee of Institut Pasteur to have the right to have its product developed and manufactured by Novasep.

“This is particularly relevant for early stage clinical companies, that need to have a safe access to this patented technology,” Bléhaut said.

Financial details have not been divulged.

Gene therapy capabilities

Access to the platform bolsters Novasep’s viral vector production abilities.

The CDMO has capabilities to produce lentiviral vector supporting both clinical and commercial needs with production scale capable up to 2,000L single-use bioreactor, as well as process development, Fill & Finish, QC, QA and regulatory support.

“Novasep has extensive experience in developing and manufacturing all classes of viral vectors for gene therapy, cell therapy, immunotherapy and vaccination, such as lentiviral vectors, AAVs, ADVs, oncolytic vaccines, etc,” said Bléhaut.

“Novasep’ manufacturing facilities located in Gosselies and in Seneffe, Belgium can support flexible production technologies; We can provide adherent cell-based and suspension cell-based processes; Viral vector purification can be performed by standard ultracentrifugation based processes or scalable chromatographic processes.”