The contract development and manufacturing organization (CDMO), Yposkesi, was chosen by Genethon and Sarepta to provide commercial adeno-associated viral vector (AAV) micro-dystrophin material, in order to support a co-development project between the two companies.
The two developers entered a collaboration in 2017 to discover gene therapies for Duchenne muscular dystrophy (DMD), and extended the partnership after a potential treatment showed positive pre-clinical results. The product is currently in early clinical development stage.
Yposkesi was selected by Genethon and Sarepta to support their gene therapy development project due to its “proprietary suspension production process using a distinct producer clone and a specific transfecting agent,” Yposkesi stated.
Alain Lamproye, the company’s CEO, commented that this process is suitable for the production of a treatment for DMD, which requires high doses of AAV material.
A spokesperson for the company told us that the production of the clinical grade AAV for the DMD program has already begun, with several batches scheduled to be produced in 2020.
Since the company's launch in 2016, Yposkesi's investors have agreed on and are planning the expansion of its manufacturing capacity, a spokesperson for the company told us.
According to the spokesperson, Yposkesi's current manufacturing plant already has 'significant' capacity, with four manufacturing suites, and 'several' 200L bioreactors. "This capacity allows us to manufacture clinical grade of AAVs to supply trials within the neuromuscular field," the spokesperson added.
However, new drug products in developers' pipelines have therapeutic indications that require high doses, especially in the neuromuscular field, explained the spokesperson, adding that this trend drives this demand for capacity expansion and large-scale manufacturing.
In 2017, the company began the design of a new facility to be built next to its current facility, within the Genopole biotech hub in Corbeil-Essonnes, Paris, France.
This new 5,000-square-meters site, which will double the company's footprint, will be completed in 2022, with commercial batches expected to be delivered from the site by 2023.
The expansion is expected to enable the company to better serve gene therapy developers, especially those facing manufacturing bottlenecks, such as "the ability to supply enough clinical grade material cost-effectively, the available capacity, a production platform based on a suspension process, with demonstrated scalability."
Yposkesi's spokesperson commented that the market demand for viral vector will rise significantly over the coming years, "as a consequence of the several product approvals which occurred recently and the increase of the number of ongoing clinical trials."