FMT Preparations for Clinical Research
OpenBiome’s Clinical Research program offers three preparations of cGMP fecal microbiota transplantation products for clinical trials.
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.
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.
For more information regarding the our FMT Preparations for Basic Science Research, please review our Basic Science Research Collaboration Guide or contact us at firstname.lastname@example.org.
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