Engineered Living Therapeutics (ELTs) involve the design of live, genetically modified microbes that can sense specific conditions within the human body and respond with therapeutic actions.
ELTs address unmet needs in treating metabolic disorders, gut diseases, and other conditions where localized, sustained therapeutic delivery is beneficial but challenging with traditional pharmaceuticals.
These microbes are engineered to carry synthetic genetic circuits. When introduced into the patient's body, they can detect particular environmental or physiological signals and produce a targeted response, such as neutralizing harmful substances or producing essential drugs directly at the site of action.
The manufacturing process involves genetic engineering to introduce specific genes or circuits into bacterial cells. These cells are then cultured under controlled conditions before being packaged for clinical use.
Cells are typically engineered using CRISPR-Cas9 or other gene editing tools, followed by validation of the engineered microbes' functionality and safety in vitro and ex vivo. Preclinical testing is conducted to ensure efficacy and safety prior to human trials.
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