First-of-its-kind, state-of-the-art manufacturing facility with capacity to produce treatment for thousands of patients suffering from rare genetic disorders or life-threatening diseases
With 300,000 square feet (27,870 square meters), it is the largest dedicated cell-and-gene-therapy manufacturing facility in the world
Facility to reach 200 full-time staff by end of 2018 and continue to recruit high-value positions as market demand increases
Creates alliance with Allogene Therapeutics, a biotechnology company co-founded and led by former executives of Kite Pharma that is positioned to expedite the development of allogeneic CAR T cell therapy
Allogene Therapeutics, a Two River portfolio company, was formed with one of the largest Series A financings in biotechnology of $300 million from a premier investment consortium that includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer and Pfizer
Pfizer will hold a 25 percent ownership stake in Allogene Therapeutics
Cesca Therapeutics is making big moves to become a player in the CAR-T space. In recent months it filed a a patent application for innovation to its CAR-TXpress™ technology, signed a license agreement with China’s IncoCell Tianjin Ltd. for CAR-T related CDMO services in Asia, and is continuing development of Thermogenesis’ novel CAR-TXpress platform.
The company also recently announced the launch of its 2nd gen AXP® II system for isolating and collecting hematopoietic stem cells (HSCs) from umbilical cord blood and peripheral blood. Since the launch of its first AXP® system, Cesca has been a leader is cord blood processing technologies.
March 13, 2018 03:39, TOKYO — SanBio Group and Hitachi Chemical Co., Ltd. (Hitachi Chemical) jointly announced today that, through an agreement with Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS; formerly PCT Cell Therapy Services, LLC), Hitachi Chemical’s US subsidiary that engages in contract manufacturing and development of regenerative medicine products*1, they will manufacture SB623, a proprietary regenerative medicine product under development by SanBio. Under the agreement, late stage clinical products and commercial products of SB623 for the US and Japanese markets will be manufactured using Hitachi Chemical’s global facilities. [Read more…]
In major news released today, MiMedx Group announced that their AmnioFix® Injectable was awarded RMAT status by the U.S. FDA. This is the third RMAT designation awarded by the FDA this year and the 15th RMAT overall since the designation was introduced by the 21st Century Cures Act. The “Regenerative Medicine Advanced Therapy” (RMAT) Designation was introduced on December 13, 2016, when Congress included several provisions in the 21st Century Cures Act, an act signed into law by the 114th United States Congress authorizing $6.3 billion in funding, the bulk of which is allocated for programs supported by the National Institutes of Health (NIH).
The 21st Century Cures Act has had a profound effect on the regenerative medicine industry, supporting expansion of this industry to 600+ companies worldwide. The act also accompanies accelerated regulatory pathways that have been introduced in several other countries worldwide, including Japan, South Korea, and the E.U.
Within the U.S., sponsors of cell and gene therapies are eligible to obtain an RMAT designation if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it could address unmet medical needs. [Read more…]