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Contract development and manufacturing organization (CDMO), Yposkesi, has entered into an agreement in principle with Axovant Sciences.
Contract development and manufacturing organization (CDMO), Yposkesi, has entered into an agreement in principle with Axovant Sciences, which develops innovative gene therapies for neurologic and neuromuscular diseases.
If the agreement in principle is executed, the strategic partnership formed between the companies would see Axovant receive reserved capacity for cGMP-grade adeno-associated virus (AAV) production. This manufacturing capacity would include dedicated suite space and ongoing prioritized access to manufacturing resources for Axovant’s AAV-based gene therapy programs, from the development stage all the way through to commercialization.
Yposkesi’s gene therapy manufacturing capabilities for AAV and lentiviral vector production includes its current 50,000-sq.-ft facility, which houses multiple independent manufacturing suites for bulk drug substance and fill and finish. The company is planning to extend its capacity in 2019 to support commercial production and by 2021 is anticipates and expansion of its global footprint to 100,000 sq.-ft.
Through the strategic partnership, Axovant will have access to Yposkesi’s manufacturing processes, which comply with both European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) manufacturing requirements for phase I-III clinical trials.
“We are very pleased to partner with Axovant to support the manufacture and delivery of its innovative gene therapies on a large scale,” said Alain Lamproye, CEO of Yposkesi in a Nov. 28, 2018 press release. “Leaders in gene therapy, such as Axovant, are drawn to our state-of-the-art facilities, robust manufacturing capacity, and years of expertise in producing cGMP-grade material. We look forward to contributing to advancing Axovant’s innovative and robust gene therapy pipeline.”