Stem cell biotechnology company Asymmetrex has been awarded a Technical Project grant from Advanced Regenerative Manufacturing Institute (ARMI) BioFabUSA. The new grant supports studies by Asymmetrex to evaluate its kinetic stem cell (KSC) counting technology as a method for determining a long-needed critical quality attribute for the biomanufacturing of potent therapeutic tissue stem cell-based products.
In 2020, stem cell biotechnology company Asymmetrex became a new member company of the Advanced Regenerative Manufacturing Institute (ARMI). Asymmetrex’s focus on developing practical methods for quantification of therapeutic tissue stem cells was recognized by ARMI as an important enabling technology in its mission. ARMI is working to accelerate progress in the U.S. cell and tissue biomanufacturing industry by leading the development of standardized, automated, scalable, and environmentally closed processes that consistently provide patients with effective products for regenerative medicine.
Many current and envisioned cell and tissue therapy products are based on tissue stem cells – for example, blood stem cells found in the bone marrow, muscle-derived stem cells, umbilical cord tissue and blood stem cells, and even stem cells derived from fat tissue. The number of stem cells is recognized as an important critical quality attribute for determining how well stem cell-based biomanufacturing proceeds and how effective its products are as treatments for patients.
Despite the importance of knowing tissue stem cell number, until Asymmetrex introduced its kinetic stem cell (KSC) counting, there was no method available for quantification of the many different types of tissue stem cells of interest for cell and tissue biomanufacturing. Now with ARMI support, Asymmetrex is automating and customizing its KSC counting technology, so that it is more compatible with the specific needs of cell biomanufacturing processes. The company is now partnering with other ARMI member companies and ARMI|BioFabUSA development teams to integrate its technology and evaluate its effectiveness for improving production quality and consistency in ongoing cell and tissue biomanufacturing development projects.
Asymmetrex’s President and CEO, James L. Sherley, M.D., Ph.D. reports excellent progress made in the first several months of the project. “Working with ARMI scientists and bioengineers has given us better knowledge of important needs in the cell biomanufacturing industry that our technology can effectively address. It’s terrific to be working with partners who immediately get how our technology can help them achieve their goals and who are excited to engineer and evaluate its implementation.”
Tom Bollenbach, Chief Technology Officer ARMI|BioFabUSA, related that, “With the novel techniques developed by Asymmetrex, we have a new set of tools that can be applied across many projects to evaluate stem cell fraction, and it’s exciting to realize that this information will be a huge help in process development. We now have a way to evaluate the stem cell fraction of our starting material – in this case, different sources of stem cells – and a way to evaluate which process changes have the most positive impact on our stem cell populations. This knowledge will help us make process decisions that improve final product quality and cost of manufacture – two key factors in the success of these projects.”
Sherley has a vision that ARMI’s endorsement will inspire other member companies to partner with Asymmetrex beyond the completion of the current project. He has a particular interest in companies that produce automated counters for general tissue cells. The data output of these instruments is the input for Asymmetrex’s KSC counting software. One focus of Asymmetrex’s business model is partnering to integrate its software into an existing general cell counter to develop and market the first automated tissue stem cell counters. Sherley beams, “They may not realize it now, but stem cell science, stem cell medicine, and, of course, cell and tissue biomanufacturing are all going to want this instrument!”
Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets kinetic stem cell (KSC) counting, the first technology for determination of the dose and quality of tissue stem cell preparations for use in stem cell transplantation therapies and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA (ARMI).