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Takara Bio Establishes Foothold in the Pluripotent Stem Cell Market

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Takara Bio EuropeTakara Bio broke news that the Medical Products Agency (“MPA”), the Swedish national authority responsible for regulation of drug and medical products, granted the company a manufacturing license for derivation and banking of human embryonic stem (hES) cells to be produced under GMP conditions. The cells will be produced at Takara Bio’s manufacturing laboratory located in Göteborg, Sweden, within Takara Bio Europe’s facility.

The announcement caught my attention, because to the best of my knowledge, Takara Bio is the first company worldwide to offer this service for human ESCs.

Takara Bio’s Role with Human Pluripotent Stem Cells

The significance of this event is that Takara Bio is now capable of providing a safe, reliable source of hES cells for future cellular therapeutic development by sourcing starting material from FDA-compliant facilities according to FDA guidelines and leveraging its proprietary, feeder-free hES cell establishment method, which is animal- and human-component free. [Read more…]

Cell Therapy Manufacturing | Factors Driving Interest in Cell Therapy CDMOs

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Cell therapy manufacturing is becoming of growing importance as more and more cell therapeutics make their way through clinical trials. One of the major issues with moving cell therapy products from “bench to bedside” has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing.

Cell Therapy Manufacturing CDMOs

While these realities may sound like negative factors for the industry, the reality is quite the opposite. For cell therapy CDMOs, these factors create pressures for cell therapy companies to seek third-party partners who possess technical, manufacturing, and regulatory expertise in cell therapy development and manufacturing. [Read more…]

Stem Cell Infusion: What to Expect

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In recent years, stem cell infusion has become a breakthrough technology. There have been multiple medical leaders citing regenerative medicine as the way of the future. Stem cells obviate our need to patch up the body or create stopgap measures for systems that don’t work. They instead promise to replace organs and tissues that no longer function, essentially rebuilding the body from the inside out. Naturally, science has not progressed to the point of spreading this technology across the globe. However, the growing availability and efficacy of stem cell infusion indicate this isn’t far off, either. [Read more…]

Mogrify Raises $3.7M for Direct Cell Reprogramming and Appoints Dr. Disley CEO

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MogrifyMogrify (Cell Mogrify Ltd) is a private biotechnology company has developed a direct cellular conversion technology to allow for the transformation (transmogrification) of any mature human cell type into any other – without going through a pluripotent stem cell- or progenitor cell-state. [Read more…]

What is the difference between totipotent, pluripotent, and multipotent?

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A common question is, what is the difference between totipotent, pluripotent, and multipotent cells? The answer is simple. Totipotent stem cells are the most versatile stem cell type, because they are formed shortly after fertilization of an egg cell by a sperm cell. They can become all of the cells of the human body, as well as the cells of the embryo and developing fetus.

At about four days into development, these totipotent cells specialize slightly, becoming pluripotent stem cells. [Read more…]

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