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
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…]
Cytori developing cell therapies that harness the unique attributes of adipose-derived regenerative cells (ADRCs)
40 patients enrolled among 5 French centers: Marseille, Montpelier, Rouen, Lyon, and Paris
SAN DIEGO, Jan. 22, 2018 — Cytori Therapeutics, Inc. (NASDAQ:CYTX) announces completion of patient enrollment in SCLERADEC II (NCT02558543), a randomized, double-blind, placebo-controlled, parallel group, multi-center clinical trial intended to study the safety and efficacy of Habeo™ Cell Therapy in up to 40 subjects with impaired hand function due to scleroderma (systemic sclerosis). [Read more…]
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).
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…]