Unlocking the therapeutic potential of the human microbiome

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Our proprietary and scientifically rigorous bacteria strain selection methodologies includes analyzing relevant strains using our bioinformatics expertise and testing candidate bacteria in preclinical models.

A robust inventory of well-characterized pure beneficial live bacteria strains produced under cGMP conditions.

A novel dual-release delivery technology designed to enable oral targeted delivery of biologics, including live bacteria, to the lower GI tract.

Assembly is building a GMP bacteria strain inventory by isolating bacteria recovered from highly screened source donors and then identifying them by sequencing. In collaboration with academic experts, Assembly selects a subset of these bacterial strains based upon demonstrated correlations with health outcomes in individuals who have recovered from specific diseases or disease states. These selected bacteria are then manufactured reproducibly—they are grown in pure cultures under anaerobic conditions that are easily convertible to scalable GMP conditions.

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Proprietary & scientifically rigorous strain selection

  • Proprietary in silico strain selection strategies and methods
  • Human FMT studies
  • Sequencing and analysis protocols
  • In vitro and in vivo models
  • GMP cell banking of pure strains
  • GMP production of bulk material
  • Scale-up

While FMT works, a better approach is needed as the widespread adoption of FMT is problematic.

Assembly has a built a broad-based platform to enable live biotherapeutic products (LBP) product development across a number of therapeutic areas. Our list of targeted indications include IBD (ulcerative colitis and Crohn's disease), IBS, immuno-oncology, NASH and metabolic diseases. We are motivated to work with partners across a number of disease areas and we have built our drug discovery and manufacturing capabilities to facilitate these interactions.

Our integrated platform for strain selection, cGMP manufacturing and targeted Gemicel® delivery allow Assembly to rapidly and efficiently address numerous therapeutic indications, both on our own and with a variety of partners.

Gastroenterology

In partnership with ALLERGAN

  • Inflammatory Bowel Disease (Ulcerative Colitis and Crohn’s Disease)
  • Irritable Bowel Syndrome

Liver Disease

  • PSC
  • Non-alcoholic Steatohepatitis (NASH)

CNS

  • Neurodegenerative Neurodevelopmental

Oncology

  • Colorectal cancer
  • Immuno-oncology

Metabolic disease

  • Obesity
  • Diabetes

Infectious Disease

C. difficile (CDI)

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Assembly entered into a collaboration and license agreement with Allergan to jointly develop our microbiome assets for IBD, IBS and other microbiome-related GI indications.

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With our strong R&D and fully integrated platform technology, we seek value-added collaborations with academic and corporate partners across therapeutic areas for our Microbiome platform.

If your organization is interested in collaborating with Assembly please contact BD@assemblybio.com.