Genethon, Sarepta Choose Yposkesi as Mfg. Partner
CDMO’s capacity to produce AAV materials at large-scale will support Genethon and Sarepta’s project to take micro-dystrophin to clinical trials this year.
Yposkesi, a full-service contract development and manufacturing organization (CDMO) for preferred access and reserved capacity for cGMP grade viral vector production, has been selected to produce clinical and large-scale commercial AAV micro-dystrophin material within the co-development program between Genethon and Sarepta Therapeutics focused on Duchenne muscular dystrophy.
Genethon and Sarepta recently said they are extending their collaboration on developing an innovative gene therapy for Duchenne muscular dystrophy, which has demonstrated significant efficacy in pre-clinical testing. Yposkesi’s selection to produce clinical and large-scale commercial batches is based on its innovative proprietary suspension production process using a distinct producer clone and a specific transfecting agent.
Yposkesi is currently doubling the size of its production facilities to increase volume capacity of its bioreactors, enabling it to meet its clients’ growing needs. With the construction of an additional 5,000 square meter site underway, Yposkesi plans to deliver commercial batches in 2022/2023.
“Yposkesi is proud to have been selected to produce and deliver AAV material at large-scale using its proprietary suspension-based process for Duchenne muscular dystrophy, a neuromuscular disease that requires high doses,” said Alain Lamproye, chief executive officer, Yposkesi. “The significant investments made in honing our expertise, expanding our facilities, as well as developing innovations to increase production capacity and process efficiency are aimed at serving gene therapy developers, especially those currently facing a bottleneck in manufacturing.”
Written by: Contract Pharma
Published on: 01.09.20