MINNEAPOLIS, MN, December 20, 2023 — Bio-Techne Corporation (NASDAQ: TECH) has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ExCellerate™ GMP iPSC Expansion Medium, Animal Free (CCM0036-GMP), supporting the development and manufacture of regenerative medicine and stem cell therapies. [Read more…]
Interview With Kaz Hirao, President & COO at Fujifilm Cellular Dynamics
Fujifilm Cellular Dynamics is the largest provider of induced pluripotent stem cell (“iPSC” or “iPS cell”) products worldwide. In addition to being a global leader for life science products, CDI divided into two business units (Life Science and Therapeutics), positioning it to further invest in the development of iPSC-derived cell therapeutics.
The company also opened a $21M cGMP production facility to support its internal cell therapeutics pipeline, as well as serve as a CDMO for iPS cell products.
CEO of Applied StemCell (ASC), Dr. Ruby Chen-Tsai, on ASC’s Massive Plans for Expansion
In this interview with Dr. Ruby Yanru Chen-Tsai, CEO of Applied StemCell (ASC), we explore ASC’s recent acquisition by QHP Capital, new hires being added by the company, upcoming product launches, and the company’s plans for massive expansion in 2024 and beyond.
We also explore the critical importance of developing readily available, off-the-shelf cell and gene therapies (CGT) at scale and for affordable price points. Enjoy! [Read more…]
Takara Bio Establishes Foothold in the Pluripotent Stem Cell Market
A few years back, Takara Bio announced that the Medical Products Agency (“MPA”), the Swedish national authority responsible for regulation of drug and medical products, had granted the company a manufacturing license for derivation and banking of human embryonic stem (hES) cells to be produced under GMP conditions. The cells were to be produced at Takara Bio’s manufacturing laboratory located in Göteborg, Sweden, within Takara Bio Europe’s facility.
This announcement made Takara Bio 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 capable of providing a predictable and 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…]
Century Therapeutics Progressing CNTY-101, its iPSC-derived CAR NK Cell Candidate, Into a Phase 1 Trial
Represents second IND clearance for CNTY-101, the Company’s lead iPSC-derived CD19-targeted CAR NK cell product candidate, and first in an autoimmune and inflammatory disease indication
Company plans to initiate the Phase 1 clinical trial in the first half of 2024; initial data expected by year-end 2024
CNTY-101 is the first cell therapy product candidate engineered with six precision gene edits including a CD19-CAR, Allo-Evasion™ technology, IL-15 cytokine support and a safety switch
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