“Sudhin Biopharma Company became familiar with ARMI during several networking meetings at NIIMBL and heard your CTO, Thomas Bollenbach, speak about ARMI at the conference on the “Business of Regenerative Medicine” at U Penn Medicine last summer, 2018,” said Dhinakar Kompala, Founder & CEO, adding “We discussed the benefits of joining ARMI with Tom and are now glad to become a new member.”
Sudhin Biopharma is an early-stage Biopharma technology development company located in Superior, CO, founded in 2014 by Prof. Dhinakar Kompala, after taking early retirement from his faculty position in the department of Chemical and Biological Engineering at the University of Colorado, Boulder.
“Sudhin Biopharma hopes to gain deeper understanding of the critical issues in regenerative medicine through its membership in ARMI and participation in its technical meetings. We hope to collaborate with ARMI member companies and develop novel manufacturing strategies for organoids using our single use disposable BioSettler during their harvest, washing and concentration operations. We will seek funding from ARMI for such collaborative projects with other ARMI members,” Dhinakar explained.
The company’s core specialty is in gentle separation of cells and particles by exploiting their different sedimentation velocities (primarily determined by their size and secondarily by their density) through enhanced sedimentation on inclined surfaces. About 30 years ago, in their initial application to modern bioprocessing, Prof. Kompala’s research group in Colorado demonstrated that the inclined settlers can remove the smaller dead cells and cell debris selectively from the settler and recycle all the live and productive mammalian cells back to the bioreactor.
“We hope to share our long experience with unique capabilities of inclined settler technology, such as gentle separation of cells and particles based on the different sedimentation velocities (determined by size and density) to separate organoids from iPSCs; harvest, wash, and concentrate ex vivo expanded MSCs from microcarrier beads; and other manufacturing steps for regenerative medicine,” said Dhinakar.
Following Prof. Kompala’s demonstration of inclined settler technology for mammalian cell cultures at University of Colorado, some biopharmaceutical manufacturing companies have quickly scaled it up for large-scale production of therapeutic biologics in high cell density perfusion bioreactors. Sudhin Biopharma has recently developed a novel compact cell settler design with 6 – 10x more settling surface area over a given footprint compared to its traditional lamellar scale up design. With this novel patent-pending scale-up design, Sudhin Biopharma has demonstrated that this compact settler can be used to recycle even smaller microbial yeast cells to achieve high cell viabilities and high bioreactor productivities over an extended culture duration of a high cell density perfusion bioreactor lasting several months.
“We are now developing novel harvesting technologies using our BioSettler in the biopharmaceutical manufacturing industry. These biopharmaceutical harvesting technologies can readily be translated into gentle harvesting, washing and concentration of regenerative medicine products,” he explained, adding, “We are also developing novel bioreactor designs incorporating compact settlers inside bioreactors, which will be useful for expansion of cell therapy and regenerative medicine products as well.”
“One of the early customers for our single use disposable BioSettler is finding it useful in gentle separation of differentiated organoids from single iPSCs. Starting with this customer-initiated application, we became aware of several other applications for our BioSettler in the regenerative manufacturing industry,” Dhinakar said. “Our BioSettler can be used for gentle harvest, washing and concentration of several autologous and allogeneic therapeutic cell types, e.g. CAR-T cells, MSCs, islets, etc. and we are excited to find our expertise in large-scale mammalian cell cultures translate readily into novel methods in manufacturing of cell therapies and further in the manufacturing of regenerative medicine.”
Sudhin Biopharma Co. is also a Tier 3 (SME) member of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a related Manufacturing USA institute funded by NIST/DOC.
“The development of our compact cell settler into a single use disposable plastic BioSettler was funded by NIIMBL for its potential applications in Biopharma industries, such as a selective cell retention device for perfusion bioreactors, clarifier of cell culture broth from fed-batch bioreactors, and harvest, washing and concentration of HEK cells for production of gene therapy vectors,” Dhinakar explained.
A cell therapy/regenerative medicine company is now testing the Sudhin single use BioSettler to harvest organoids (~500 microns) from stem cells (20 microns). Other cell therapy applications of the company’s gentle cell/particle separation technology include: (i) facile separation of mesenchymal stem cells from microcarrier beads (~500 microns) after ex vivo expansion and enzymatic separation; (ii) selective removal of dead cells and cell debris from in vitro expanded CAR-T cells to improve the cell viability; and (iii) gentle concentration, harvest and washing of stem cells, CAR-T cells, etc.
“We hope to share our long experience with unique capabilities of inclined settler technology, such as gentle separation of cells and particles based on the different sedimentation velocities (determined by size and density), to separate organoids from iPSCs; remove dead cells and cell debris from CAR-T cells; harvest, wash, and concentrate ex vivo expanded MSCs from microcarrier beads; and other manufacturing steps for regenerative medicine,” Dhinakar concluded.