Advances in LBP Manufacturing: Microbiotica and Biose Industrie Prepare for Clinical Studies

Microbiotica, a biotechnology firm focused on developing precision microbiome medicines known as live biotherapeutic products (LBPs), is preparing for clinical trials targeting advanced melanoma and ulcerative colitis. The company will present its manufacturing progress at the 9th Microbiome Movement Drug Development Summit in Boston.

Microbiotica's proprietary microbiome profiling platform supports drug discovery by precisely identifying bacteria linked to favorable clinical outcomes in specific patient populations. The company combines expertise in microbiology, bioinformatics, translational biology, and LBP manufacturing to advance its therapeutic pipeline.

Microbiotica's lead programs, MB097 for advanced melanoma and MB310 for ulcerative colitis, are scheduled to enter clinical studies this year. To support these trials, Microbiotica has collaborated with Biose Industrie, a contract development and manufacturing organization (CDMO) specializing in microbiome therapeutics. This partnership aims to produce clinical trial batches compliant with current Good Manufacturing Practices (cGMP).

Image source: Microbiotica

The LBPs developed by Microbiotica consist of specific consortia of bacterial strains identified through its microbiome discovery platform. This platform analyzes patients' gut microbiome compositions to pinpoint bacterial species associated with positive clinical responses. The manufacturing process involves developing individual protocols for each bacterial strain, which are then combined into stable, freeze-dried powders and encapsulated for oral administration.

See also: Big Investments for Human Microbiome Research

Biose Industrie has leveraged its industrial expertise to scale up the production of these therapeutic bacteria, ensuring they remain stable in a freeze-dried state. Both companies have successfully developed robust GMP manufacturing processes for MB097 and MB310.

Adam Wilkinson, Vice President of Pre-Clinical Development at Microbiotica, emphasized the collaborative effort between the two companies:

"Manufacturing biologics is inherently challenging, especially when scaling multiple processes to cGMP standards. The seamless collaboration between our teams has been crucial to overcoming these challenges."

The presentation at the Microbiome Movement Drug Development Summit will feature Adam Wilkinson and Claire Derlot, Chief Business Officer at Biose Industrie, discussing the development and manufacturing of the LBPs for the clinical studies.

Details of the presentation:

• Event: 9th Microbiome Movement Drug Development Summit
• Date: Thursday 11 July
• Time: 09.00-09.30
• Place: Boston, USA
• Session: Bringing the Cutting-Edge from the Clinic: Redefining Standards in Disease Management
• Title: “Microbiotica & Biose Industrie: Developing & Manufacturing Two multi-strain Live Biotherapeutic Products for Clinical Studies”

Topics: Novel Therapeutics