Our Manufacturing Process: Enabling CGMP Production of Defined Bacterial Consortia at Large Scale

Our new CGMP manufacturing facility enables highly scalable and cost-effective production of defined bacterial consortia, and can flexibly handle multiple drug candidates in parallel for global clinical studies and a potential commercial launch.

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A Scalable Path Forward for Manufacturing Defined Bacterial Consortia

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 first-of-its-kind large scale CGMP facility builds on Vedanta’s CMC expertise in the microbiome field and can support the global clinical expansion of Vedanta’s pipeline. With this facility, Vedanta has CGMP capabilities for defined bacterial consortia from clinical development to commercial launch, underscoring our leadership in the discovery, development, and manufacture of this new drug modality.

How Our Manufacturing Process Works

Our industry-leading process is based on the isolation and storage of individual strains of bacteria in clonal cell banks, their subsequent fermentation, lyophilization, blending into defined consortia, and filling into capsules for oral administration to the patient. 

We use proprietary processes at each step and have accumulated a wealth of institutional knowledge that has proven broadly applicable to product processing and stabilization. 

Our Manufacturing Process Consists of the Following Key Steps