Flash Therapeutics to double its clinical batch production capacity by 2022 and expand to large-scale batch manufacturing starting 2023
TOULOUSE (FRANCE), September 16, 2021 - In order to meet the rapidly growing global demand for gene, cell and RNA therapies, Flash Therapeutics is accelerating the scale-up of its biomanufacturing capabilities. This scale-up of GMP-compliant clinical batch production includes both DNA and RNA lentiviral vector technologies (proprietary LentiFlash® technology).
Today Flash Therapeutics announced the commissioning of a new biomanufacturing platform for its DNA and RNA lentiviral vectors on the Santé du Futur - Oncopole campus in Toulouse. The 800 m2 platform is housed in a module separate from that of the Pierre Fabre Innovation Centre (building majority owned by the SCPI Epargne Pierre managed by Atland Voisin). Flash Therapeutics is also relocating its headquarters and all of its 35 employees to this site.
The move will allow Flash Therapeutics to initially relocate all of its current activities and then double its clinical batch production capacity by the second half of 2022. The 800 m2 facility is already in operation and is dedicated to the production and control of research-grade vectors for biomedical research. The facility includes an area for quality control activities, 4 cleanrooms dedicated to cell culture, 2 cleanrooms dedicated to vector manufacturing and 1 cleanroom dedicated to bioreactor process development. By 2023, Flash Therapeutics will significantly expand the facility to approximately 2,000 m2 with GMP manufacturing rooms. Flash Therapeutics is already planning to produce the first clinical batch of LentiFlash® messenger RNA by the end of 2022, for in vivo administration.
As part of a partnership with the AP-HP's MEARY Cell and Gene Therapy Centre dedicated to the GMP production of experimental advanced therapy drugs, Flash Therapeutics already has GMP-compliant facilities for the production of DNA and RNA lentiviral vectors batches
To support this acceleration, Flash Therapeutics announced on September 7 that it had signed an investment agreement with TechLife Capital and Elaia Partners for at least €15M over the next three years. As a reminder, a first tranche of €4M paid in July 2021 is dedicated to the development of its biomanufacturing infrastructure and the strengthening of its commercial, process, analytical and production teams. Six recruitments are already planned by the end of 2021 with the objective of doubling the workforce within two years.
Pascale Bouillé, President of Flash Therapeutics commented: "All of Flash Therapeutics' employees and I are very pleased to be joining the internationally renowned innovation centre that is the Oncopole - Health of the Future campus in Toulouse. I would like to warmly thank Eric Ducournau, CEO of the Pierre Fabre Group, for giving us the opportunity to move into this high-tech industrial premises adapted to our development, in complete independence. This will enable us to continue to provide long-term support to all our customers and their projects, by being a key international industrial partner for gene and cell therapy programs (genetic, infectious and cancer diseases) and vaccines.”
"The rapid growth of gene and cell therapies, the growing number of products in clinical trials and the need for vaccines are driving the increase in global demand for vector production. With the aim to produce large-scale clinical batches, we are now positioning ourselves to meet this demand by becoming a world leader in the biomanufacturing of DNA and RNA lentiviral technologies. We now offer a true continuum of high-purity vector manufacturing from research to clinical phases, representing a source of acceleration for our global customers, which are laboratories and biotechnology companies," added Pascale Bouillé.
About Flash Therapeutics
Founded in 2005 and based in Toulouse, France, Flash Therapeutics is a gene therapy company that develops and produces DNA and RNA transfer technologies for the development of innovative therapies. Thanks to its scalable biomanufacturing processes, the company offers a manufacturing continuum (from research to the clinic), accelerating the clinical proof of concept of new drugs. In particular, the company's proprietary LentiFlash® delivery technology, mediated by a lentiviral particle carrying only RNA, is dedicated to vaccination, gene editing and other disruptive therapeutic approaches. More information on www.flashtherapeutics.com.
Jean-Christophe Huertas (+33 6 16 99 47 05) – firstname.lastname@example.org