Research – RegenMed Development Organization

ReMDO conducts regenerative medicine research with an ultimate goal to de-risk and accelerate the transition of regenerative medicine technologies to the global market and speed up the translation to clinical practice to help make patients lives better.

The research portfolio is comprised of four programs funded by public-private partnerships between the government, industry, and academic teams.

Universal Bioink Program

Standardized Cell Culture Media

Scalable RegMed Bioreactor

Cell Isolation Program

Universal Bioink Program

The ReMDO Universal Bioink program is developing sets of hydrogels to be used as a tunable bioink that will not need to be designed from scratch, but rather be more like an out-of-the box bioink that could be used across different bioprinting platforms (e.g. extrusion, ink jet, etc.), and compatible with supporting different cell types (e.g. endothelial cells or cardiac cells).

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The bioink program aims are to develop a universal bioink that can work across different 3D bioprinting platforms and can be tuned to match different levels of stiffness and biochemical profiles of human tissues. By the end of our program we will have a prototype product that could be commercialized by any one of our industry collaborators.

Some of the important considerations that we making in the design of our Universal Bioink program include thixotropy (change of physical properties in response to stress), biomechanical tuning, and biochemical tuning. Thixotropy could be thought of as when you squeeze a tube of toothpaste, the paste is extruded out from the pressure and is then able to maintain its shape on your toothbrush. If a bioink is too much like a liquid it will simply form a puddle after being bioprinted. If the bioink is too firm it will clog the printing nozzle. These are some of the many challenges associated with getting it right.

The biomechanical tuning allows us to bioprint structures at different resolutions and mimic stiffness ranging from bone and cartilage to soft tissues like liver, brain, and heart. Biochemical tuning ensures that the correct environmental needs (e.g. growth factors, extracellular membrane proteins, etc.) are contained within the bioink to support the cells and tissues being bioprinted. Still another major challenge for design of bioinks is also being able to bioprint fine structures such as vascular and neuronal networks which still remains a challenge for the field.

Standardized Cell Culture Media

Standardized cell culture media—liquids that support cell growth.

The overall objective of the media program is to develop a well-defined, xeno-free basal medium that supports the growth and viability of human cells derived from each of the three germ layers, and that can be used in conjunction with three specific supplements, each of which has been optimized to support the expansion of cells. These germ layer-specific formulations will then be augmented with additional factors tailored to support the growth and function of several specific human cell types commonly employed in regenerative medicine. Because all formulations will be derived from the same “universal” basal medium, review by domestic and regulatory agencies will be greatly simplified and manufacturing costs will be substantially lowered.

The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. In partnership with the Department of Defense and private support, MTEC is working to prevent injuries and accelerate the development of revolutionary medical solutions. ReMDO’s collaboration aims to advance biomedicine and create amazing new possibilities.

Bioreactor

The ReMDO Bioreactor Program seeks to develop a universal standardized bioreactor platform for the maturation of regenerative medicine clinical products. The system will be scalable across the clinically relevant range and configurable for clinically relevant construct geometries.

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All materials used in the construction of these bioreactors will be considered in terms of sterilization, molecule binding potential, chemical leeching and cost. The design concept will include a standardized docking platform that is able to deliver both mechanical and electrical input to the bioreactor module. The docking platform will interface with a controller module through which the bioreactor may be operated and monitored. User-friendly software will be developed to allow easy programming and operation of the platform.
The bioreactor itself will be a disposable unit that receives magnetic mechanical input. These magnetic fields will be used to drive pump valves and mechanical actuators without breaking containment. Electrical input will be accomplished through the use of induction coils, once again to circumvent the need for breaking containment. Within the bioreactor, interchangeable and standardized hardware will be designed to allow the bioreactors to be configured for any desired application. A limited suite of integrated and disposable sensors will be used to monitor temperature, flow, O₂ lactate and glucose. The latter of these parameters will inform automated O₂ generation and batch feeds, respectively.
The platform will comply with regulatory standards, thus simplifying and reducing the cost and time associated with the development of processes for the manufacture of engineered tissues.

Cell Isolation Program

The ReMDO Cell Isolation Program will combine several cutting-edge cell isolation and purification strategies into an automated system for consistently generating the cell populations. The goal is to develop a standardized and automated platform for isolating highly-defined cell populations from biologically complex human clinical specimens for clinical manufacturing.

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This system will be designed to be configurable for any desired cell type, thereby enabling the efficient manufacture of a safe product with the required functionality. An innovative process for label-free/minimal manipulation cell isolation will involve a multi-step process that sequentially yields a population of ever-increasing purity. The final prototype cell isolation device will be tested in simulated and real-world clinical manufacturing scenarios to obtain high-purity mesenchymal stem/stromal cells (MSC) from several human tissues, working throughout in close coordination with industry stakeholders and the FDA.