FMT Preparations for Clinical Research

OpenBiome’s Clinical Research program offers three preparations of cGMP fecal microbiota transplantation products for clinical trials. This material is sourced through our contract manufacturing provider, Finch Therapeutics Group, and is available exclusively from OpenBiome as part of a long-term partnership focused on driving the pace of clinical research into the microbiome.

Formulation: Currently, three preparations are available for clinical research. These preparations are designed for Lower GI delivery (FMP250), Upper GI delivery (FMP30) and oral delivery (DE FMT Capsules). Customized formulations may be available.

Quality and Safety:  All FMT preparations are produced following industry-leading quality and safety controls in a cGMP environment. Donor screening and process controls support documentation are available here. Currently fewer than 3% of candidate donors pass screening procedures to become active donors.

Donor Selection: Beyond rigorous safety controls, partners may be able to request some additional donor characteristics in the FMT preparations used in trials for an additional fee. Pending availability of material, research partners may request donors with defined demographic or clinical backgrounds (e.g. BMI, age, gender). Partners should note that some donor characteristics may not be available in the current supply chain.

FMT Preparations for Basic Science Research

To support basic science research, OpenBiome has developed a Fecal Microbiota Preparation for Research pack (FMP-R), a microbiota preparation designed for researchers interested in developing biological tools from the bacteria found in human stool, including humanized animal models and biomarker screening methods. Furthermore, our Microbiome Metacommunity Standard (MMS) material may prove essential for researchers aiming to standardize and control sequencing runs and experiments.

FMT Microbiota Preparation for Research (FMP-R): The OpenBiome FMP-R Pack provides microbial communities from healthy human donors along with accompanying molecular and clinical characterization data to support research into the human microbiome. Each FMP-R pack includes 25 aliquots, each containing a 1 ml preparation of concentrated fecal microbiota isolated from one or more qualified OpenBiome donors, tailored to the research application. These samples can be used for both in-vitro assays and in-vivo applications (such as humanization, colonization, and competition experiments) in pre-clinical animal models.

Microbiome Metacommunity Standard (MMS): OpenBiome recognizes the significant variability in results when high-throughput technology is used to obtain raw 16s sequencing data. In accordance with our commitment to catalyze microbiome research and improve the quality and consistency of data across our network of collaborators, OpenBiome has developed a standardization tool called the 'Microbiome Metacommunity Standard’ (MMS). 

The MMS is designed to serve as a cross-platform, cross-center benchmark for users of different sequencing platforms and variable pre-sequencing processing pipelines and to ameliorate the 'batch effect' observed across sequencing runs. MMS users may control not only for sequencing differences within their individual runs, but also among their sequencing runs and the results of any other researchers and centers using MMS.

For more information regarding the our FMT Preparations for Basic Science Research, please review our Basic Science Research Collaboration Guide or contact us at science@openbiome.org.

 

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