CYP cynata therapeutics limited

Not worth the oxygen being given. Plenty of Cynata specific...

  1. 1,299 Posts.
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    Not worth the oxygen being given. Plenty of Cynata specific literature in that regard published:

    "To avoid the risk of teratoma formation or aberrant differentiation in vivo, the CYP-001 manufacturing process was designed to ensure the absence of residual iPSCs in the final product by incorporation of the following steps: (1) after the induction of mesoderm, cells were cultured in a single-cell suspension in semisolid medium, which does not support iPSC survival; (2) cells were passed through a mesh filtration step, which eliminates small clumps of undifferentiated iPSCs; and (3) iPSC-derived MSCs were expanded in adherent cell culture conditions, which do not support survival or expansion of undifferentiated iPSCs.To confirm these mitigation steps, we conducted an experiment in which undifferentiated iPSCs were seeded in place of MSC progenitor cells in the M-CFM culture step. After culturing for a duration equivalent to that of the differentiation process, cells were collected and cultured under conditions that support the growth and expansion of human pluripotent stem cells. No iPSC colony formation was observed (lower limit of detection, 0.001%), and microscopic observations detected only single dead cells that did not attach or divide in the flowthrough fraction plated. We conclude that residual iPSCs do not survive M-CFM culture, and that any dead iPSCs in this culture are removed before the MSC expansion stage of the process, providing reassurance that the final CYP-001 product is free from residual iPSCs.The cells in CYP-001 meet the minimal criteria for defining multipotent MSCs as proposed by the International Society for Cell and Gene Therapy19,25. The process is highly efficient, yielding a homogenous population of CD105+, CD73+, CD90+, CD43/45–, CD31– and HLA-DR− MSCs (Supplementary Table 1).We developed a new assay to quantitate potential residual undifferentiated stem cells by measuring the LIN28 gene, which is associated with the pluripotent stem cell state. Samples were subjected to a procedure that selectively amplifies the growth of undifferentiated iPSCs in a background of MSCs, to increase the sensitivity of quantitative reverse-transcription polymerase chain reaction (qRT–PCR) for residual iPSC detection (lower limit of detection, 0.001%). We also performed an in vitro tumorigenicity assay to detect the potential presence of transformed cells capable of colony formation in soft agar. No contaminating undifferentiated iPSCs or colony formation in soft agar have been detected in any batch of CYP-001 manufactured to date.
    https://www.nature.com/articles/s41591-020-1050-x#citeas

    "Additionally, the process and quality control tests were designed to ensure the absence of residual undifferentiated iPS cells in the final product to avoid the risk of teratoma formation, which is a defining characteristic of undifferentiated pluripotent cells12."
    https://www.nature.com/articles/s41591-024-02990-z

    Patent:
    Pluripotent stem cell assay
    https://patents.google.com/patent/WO2018090084A1/en

    Further livensing deal:
    https://www.scottishlifesciencesassociation.org.uk/news/sistemic-ltd-announce-a-milestone-global-service-and-license-agreement/

    Haters gonna hate, doubters gonna doubt and half-wits gonna refer to their half-baked and outdated research. I'm tempted to make further remarks, but simply not worth it.
 
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