Mass Production of Stem Cells Possible with 3D Bioreactors Starting Next Year
Significant Step Closer to Commercialization of Stem Cell Therapies
[Asia Economy Reporter Hyungsoo Park] SCM Life Sciences is partnering with US-based PBS Biotech to mass-produce stem cells. SCM Life Sciences is expected to officially begin preparations for commercial production of stem cell therapeutics using PBS Biotech's 3D bioreactor.
SCM Life Sciences and PBS Biotech announced on the 12th that they have signed a contract for the development and optimization of large-scale stem cell production processes.
They plan to complete the development of an 80-liter scale 3D large-scale stem cell production process by the first half of next year. Unlike antibody drugs such as biosimilars, cell therapeutics can be commercially produced on a global scale at around 80 liters.
From last year through the first half of this year, SCM Life Sciences and PBS Biotech confirmed the feasibility of large-scale production process development for SCM Life Sciences' stem cell therapeutics using PBS Biotech's Vertical-Wheel type 3D bioreactor in a pilot project.
Most bio companies produce therapeutic stem cells using a so-called 2D culture system, where stem cells are grown attached to the bottom of plastic culture vessels. However, stem cells cultured in 2D systems have high production costs, making market expansion difficult.
The 3D culture system has the advantage of enabling mass production of cells with consistent quality characteristics, making it suitable for producing cell therapeutics where living cells are the final product.
SCM Life Sciences expects significant improvements in stem cell culture efficiency and proliferation. The large-scale production process using the 3D bioreactor is anticipated to have shorter culture times and approximately five times higher production yields compared to the existing 2D culture process.
An SCM Life Sciences official stated, "Through 3D culture, we can expect increased production yield and scale per batch, along with reduced quality control costs, leading to a revolutionary reduction in production costs." They added, "We expect this to be a solution to the high production costs that have been a barrier to the commercialization of stem cell therapeutics."
SCM Life Sciences possesses next-generation high-purity stem cell therapeutics based on layer separation culture methods, allogeneic CAR-CIK-CD19 and dendritic cell-based immuno-oncology drugs (immune cell therapeutics), and overseas cGMP facilities. Their main pipelines include treatments for atopic dermatitis, chronic graft-versus-host disease, acute pancreatitis, acute respiratory distress syndrome, and liver cirrhosis in the stem cell therapeutic field, as well as immuno-oncology drugs such as the acute lymphoblastic leukemia treatment ‘CAR-CIK-CD19’ and metastatic renal cancer treatment ‘CMN-001’.
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