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2017 Marks the 1st Year That Regenerative Medicine Disrupted Healthcare

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The regenerative medicine industry has been rapidly expanding over the past few years, making it a high-value, fast-growth market. Key drivers for the market include high rates of clinical trials, accelerated pathways for product approvals, new technologies to support cell and gene therapy manufacturing, and the potential for cell therapies to revolutionize healthcare.

The regenerative medicine market gained major momentum when the Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval for a CAR-T cell therapy in the U.S. in August 2017 (Kymriah). In October 2017, Kite Pharma became the second company to get FDA approval of a CAR-T cell therapy (Yescarta).

With swelling momentum to support the CAR-T technology, there are now close to 40 companies developing redirected T cells or NK cells for therapeutic use. [Read more…]

Japan’s Laws Supporting Accelerated Pathways for Cell Therapies

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In late 2014, Japan passed two new laws that revolutionized the commercialization of cell therapies within the country by providing an accelerated pathway for product approvals. While there has been much discussion about these laws, few people have a clear understanding of the implications of these regulations on a global scale.

Below, we summarize the laws, identify their importance, and most importantly, speak to how Japan has become a “gateway country” for regenerative medicines. [Read more…]

Astellas and Universal Cells Collaborate to Utilize Universal Donor Cell Technology

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Oct. 19, 2017 — Astellas Pharma Inc. and Universal Cells, Inc. announced that Astellas Institute for Regenerative Medicine (“AIRM”) and Universal Cells have entered into an exclusive worldwide license agreement to research, develop and commercialize a novel cell therapy for an undisclosed indication. The collaboration will utilize Universal Cells’ Universal Donor Cell technology to create cell therapy products that can be administered to any recipient without the need for Human Leukocyte Antigen (HLA) matching.

Astellas collaboration with Universal Cells“I am pleased to enter into this collaboration with Universal Cells for a novel cell therapy using their proprietary Universal Donor Cell technology based on gene editing by rAAV (recombinant Adeno-Associated Virus) and cell engineering of pluripotent stem cells,” said Yoshitsugu Shitaka, Ph.D., president of AIRM. “This is definitely an important step forward in developing a potential new option as an innovative cell therapy to treat devastating diseases with high unmet medical needs.”

While the research will be conducted jointly by AIRM and Universal Cells, Astellas will lead and fully fund the development program and will obtain worldwide rights for commercialization. In consideration for the collaboration and grant of rights, under the terms of the agreement, Universal Cells is eligible to receive up to $9 million in a combination of an upfront payment and research milestones. Universal Cells is also eligible to receive research funding and further clinical development and regulatory milestone payments of up to $115 million, as well as royalties.
[Read more…]

RoosterBio Launches New cGMP Stem Cell Product Portfolio

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RoosterBio Launches New cGMP Stem Cell Product Portfolio, Maintaining Unwavering Commitment to Driving the Explosive Regenerative Medicine Industry

Next Generation Products are Harbinger of Paradigm Shift in the Adult Stem Cell Industry

RoosterBioFrederick, MD, USA. September 14, 2017 – RoosterBio Inc, today, proudly announces the launch of its CliniControl™ (CC) product portfolio, clinically-relevant starting and ancillary materials that generate unprecedented efficiencies in adult stem cell manufacturing, accelerating clinical translation of human Mesenchymal Stem/Stromal Cell (hMSC)-based therapies.  The CliniControl product portfolio will radically simplify major steps in product development and clinical translation, improving the likelihood of commercial success for RoosterBio customers.

The first in the CliniControl line of products, RoosterNourish™-MSC-CC bioprocess medium sets the new standard of industry-leading performance.  RoosterNourish-MSC-CC is a first-in-class, standardized, xeno-free (XF) bioprocess medium engineered to support not only 2D (plastic adherent), but also 3D suspension culture of hMSCs in allogeneic and autologous therapeutic manufacturing.  Formulated specifically for clinical research process and product developers, RoosterNourish-MSC-CC yields superior media productivity, leading to drastically reduced cost of goods as compared to other hMSC culture media.   The highly productive RoosterNourish medium is designed for batch 2D and fed-batch 3D cultures and seamlessly translates between culture platforms enabling scalable hMSC culture,  delivering robust, reproducible and standardized results at a commercially-viable cost of goods.  [Read more…]

Celltex Therapeutics | Interview with CEO David Eller

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David Eller CelltexCelltex Therapeutics is a regenerative medicine company that specializes in banking autologous mesenchymal stem cells (MSCs) for therapeutic use. In the Celltex procedure, a small fat sample is taken, from which MSCs are extracted, isolated, multiplied and stored for future use. Patients can then use these autologous (“self-derived”) stem cells for regenerative purposes through infusions or injections performed by a licensed physician.

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