Vedanta Biosciences, Inc.

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.

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

1. Isolation and banking of individual strains:

1. Isolation and banking of individual strains:

The manufacturing process begins with cell banks of individually isolated strains of bacteria, identified through proprietary screens as being essential members of a consortium with therapeutic potential. This approach bypasses the reliance on fecal matter donations of inconsistent composition from human donors, and eliminates the risk of pathogen transfer from such donations. We have established CGMP master cell banks for dozens of strains of gut-dwelling bacterial species and intend to significantly increase this number.

2. Fermentation:

2. Fermentation:

The bacterial strains used in our product candidates are anaerobic (requiring an oxygen-free environment) and many are spore-formers (requiring containment), which present unique manufacturing challenges. We have developed proprietary processes, including growth media and precise control conditions, that enable fermentation of anaerobes. Our in-house facilities are configured to ensure segregation and process containment, and we have developed very robust cleaning regimes. These strong features provide us with the flexibility to operate a multi-product facility, with the ability to handle both spore-forming and non-spore-forming bacteria.

3. Formulation and lyophilization:

3. Formulation and lyophilization:

Lyophilization is a freeze-drying process, whereby a product is dried by removing water under low temperature and vacuum conditions. This process can place considerable stress on bacteria and hinder their ability to regain metabolic activity when delivered to the gut of a patient. We have developed proprietary formulations to stabilize a wide range of bacterial strains, and have demonstrated stability at refrigerated temperatures for multi-year storage of our drug product capsules.

4. Blending, fill, and finish:

4. Blending, fill, and finish:

The individual strains in lyophilized powder form are blended into defined consortia and filled in capsules for oral administration that are designed to resist stomach acid and release the bacteria in the intestine. We can precisely adjust and blend each strain during drug product manufacturing to ensure that every capsule contains the same composition and dose of active ingredients. In contrast, human fecal donations intrinsically vary from donor to donor and from donation to donation, resulting in a final product with different composition and dose of each bacterial species across every batch.