News Archives | BioInformant

Takara Bio Establishes Foothold in the Pluripotent Stem Cell Market

March 20, 2019 By Cade Hildreth (CEO) 1 Comment

Takara 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…]

Cellectis Secures 82,000 Sq Ft Manufacturing Facility in Raleigh to Compliment Paris Facility

March 19, 2019 By Cade Hildreth (CEO) Leave a Comment

Cellectis, a leading French biopharmaceutic company, has signed a lease agreement for an 82,000 sq. ft. manufacturing facility in Raleigh, North Carolina, to complement its existing 14,000 sq. ft. manufacturing facility in Paris, France.

Located at 2500 – 2540 Sumner Boulevard in Raleigh, NC, the new USA facility is owned by Equus Capital Partners and will be used for clinical and commercial production of Cellectis’ leading allogeneic UCART products.

Importantly, the decision will combine the capabilities of Cellectis’ two facilities to advance its manufacturing processes and prepare for potential commercialization of its UCART products in the future. [Read more…]

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

February 25, 2019 By Cade Hildreth (CEO) Leave a Comment

Mogrify (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…]

FDA advances new efforts to promote development of safe and effective regenerative medicine products

February 18, 2019 By Cade Hildreth (CEO)

SILVER SPRING, Md., Feb. 15, 2019 — “We’re at an inflection point when it comes to cell and gene therapies. These treatments have the potential to address hundreds of vexing human diseases and conditions. When we first issued our comprehensive regenerative medicine policy framework in November 2017, our goal was to achieve a balanced and risk-based approach to support product development in cell-based therapies, while clarifying the FDA’s authorities and enforcement priorities to make sure we were protecting patients,” said FDA Commissioner Scott Gottlieb, M.D. [Read more…]

CME Regenerative Medical Event – 6th Cell Surgical Conference

February 18, 2019 By Cade Hildreth (CEO)

With the regenerative medicine market rapidly expanding, there is an increased demand for proficient, qualified medical providers to safely address the growing needs of an aging patient population. While there are numerous opportunities each year to learn these techniques, it is critical to attend events that provide targeted CME education, while expanding your mind, honing your skillset, and placing you among the world’s leaders in regenerative medicine and stem cell applications.

In our opinion, this conference represents one of the leading opportunities for medical providers to learn how regenerative cell therapy is being used across the world and how it can change your practice and your patients’ lives. [Read more…]