Manufacturing
Commercial-scale, in-house manufacturing
Vedanta was founded on the idea of using bacteria to make medicines that could be designed, tested, and manufactured with the rigorous standards we expect from pharmaceuticals.
Our therapeutic candidates are manufactured in our in-house CGMP manufacturing facilities, where we have industrialized the process for manufacturing defined bacterial consortia from clinical development to commercial launch.
1st
~10
75
manufactured in GMP facility
Our intellectual property and know-how in processes to bank, ferment, harvest, stabilize, lyophilize, and encapsulate drugs composed of multiple species of anaerobic bacteria, as well as our advanced analytical methods, have allowed us to progress multiple candidates into the clinic and manufacture supplies for what we believe to be the first-ever defined bacterial consortium drug candidate to enter a registrational Phase 3 study.
Facilities specialized in CGMP production of defined bacterial consortia
Master Cell Banks
Drug Substance Fermentation
Lyophilization
Drug Product Fill/Finish
Our overall approach is efficiently scalable and enables us to manufacture both short courses of therapy and longer or chronic courses of therapy.
Our ability to own and control the end-to-end manufacturing of defined bacterial consortia is an important pillar in our mission of developing and commercializing these novel therapeutic candidates for patients.
Intellectual Property
Vedanta has developed a broad Intellectual Property (IP) portfolio in the human microbiome field supporting internal programs as well as enabling partnerships.