| Name | Title | Contact Details |
|---|---|---|
Simone Steiner |
Chief Technical Operations Officer | Profile |
Enzyvant is also advancing the development of RVT-802, an investigational tissue-based biologic therapy for the potential treatment of primary immune deficiency associated with complete DiGeorge Syndrome. RVT-802 has been granted orphan drug designation, Breakthrough Therapy designation, Regenerative Medicine Advanced Therapy designation, and pediatric rare disease designation by the U.S. Food and Drug Administration. Enzyvant anticipates a potential BLA filing for RVT-802 in the first half of 2018. Enzyvant plans to develop treatments for additional rare diseases with high unmet need.
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Kudo Biotechnology is a global CDMO, providing world-class, end-to-end mRNA manufacturing solutions, all under one roof. Kudo has state-of the-art clinical GMP manufacturing facilities and labs in Boston, China & Singapore, making pDNA, mRNA and LNP. Kudo Bio differentiates by being a one-stop stop for all your mRNA manufacturing needs, by streamlining the process, removing bottlenecks and ensuring ease in your CMC. Our performance matches and surpasses industry-leading yields & efficiencies across all stages of the process. Our speed of 6.5 months from sequence to GMP mRNA-LNP exceeds industry platinum standards, and our quality is superior to competitors while maintaining full compliance with global regulatory requirements. Kudo Bio has a track record of accomplishing end-to-end GMP manufacturing with products entering the clinic, and successfully completing multiple batches of process validation after international technology transfer. We have an industry-leading manufacturing cGMP facility with capacity to make up to 50 GMP batches annually, with deep technology partnerships enabling access to scale-up expertise & production know-how. Finally a comprehensive quality management system with QA/QC capabilities which meet major regulatory agencies compliance requirements is paramount to delivering products to customers around the world.
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