Over the last decade, cellular therapies have advanced as a prominent new class of drugs that are effective at treating a variety of diseases. At Rise Therapeutics, we leverage safe probiotics as a carrier vehicles for protein drugs. Our drugs are dosed orally, in capsule form, to escort targeted protein therapies to the site of action, the intestinal space.
Based upon advances in synthetic biology science, Rise Therapeutics has developed the Tripartite X (TPX) drug delivery platform that enables oral delivery of biological therapies. TPX is a novel synthetic biology approach that enables encapsulation of the biological therapies inside probiotics for effective oral delivery of protein-based drugs. The approach harnesses low-cost product manufacturing and convenient oral capsule dosing and, unlike traditional biological therapies that require injection or infusion, TPX is a large step forward in the context of biologics drug development, allowing for a more convenient ‘pill-based’ oral delivery for protein therapies.
This platform approach gives us an advantage over natural commensal treatment enabling development of more potent, targeted traditional biologics-based therapies with better knowledge of mechanism of action and improved ability to define optimal dosing and pharmacodynamic effects. TPX can be utilized to deliver a variety of protein-based therapeutics, and we have interest in exploring partnership opportunities around applications of our TPX drug delivery platform to develop novel drugs for our partners.
One key to our success is the development of our flexible clean space GMP manufacturing facility that utilizes clean space isolator systems, flexible GMP quality clean room platforms consisting of a modular sets of chambers to allow clean and aseptic environment for processing and producing clinical grade GMP materials.
Our strategy enables HEPA filtered aseptic containment isolation, along with control of environmental quality parameters such as temperature, humidity, pressure, and particles. Critical cell parameters including gasses are also monitored and controlled. The systems are independent of room pressures, all gases are supplied from controlled remote tanks, all exhaust is removed to controlled remote destination via vacuum, and there is no use of room air inside our production systems.
We have equipment to support large scale production for drug substance and semi-automatic encapsulation for drug product manufacturing. Equipment to measure all necessary product release criteria are in place. Using GMP validated equipment, we assess product release characteristics and perform product stability assessments. At Rise Therapeutics, our product development focus, in-house GMP manufacturing capabilities, and microbial-based drug development experience enable rapid and efficient translation of innovative bench discoveries towards commercialization.