Minaris Regenerative Medicine is proud to share current and past news and announcements from its over twenty years of experience. Please see below for our press releases and announcements.
Munich, Germany, January 13, 2020 - apceth Biopharma GmbH, a subsidiary of Hitachi Chemical Co., Ltd. and a leading company for the manufacturing of cell and gene therapeutics, starts the commercial manufacturing of ZyntegloTM ▼, a product of bluebird bio, Inc. Today bluebird bio announced the market entry of its gene therapy Zynteglo in Germany, the first country globally where Zynteglo is ...
Munich, Germany, June 4, 2019 - apceth Biopharma GmbH, a leading company for the manufacturing of cell and gene therapeutics, will operate as the commercial manufacturer in Europe for ZyntegloTM, a product of bluebird bio. Yesterday the European Commission (EC) has granted conditional marketing authorisation for ZyntegloTM, a gene therapy for patients 12 years and older with transfusion-dependent ...
April 9, 2019 - Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS), a US subsidiary of Hitachi Chemical Co. Ltd. that engages in contract manufacturing and development of cell therapy products, and Saint-Gobain, a global leader in single-use solutions for the Biopharmaceutical industry, today announced a joint development agreement to co-develop and commercialize novel technology ...
April 3, 2019 – We are pleased to announce that Hitachi Chemical Co. Ltd. (Head Office: Chiyoda-ku, Tokyo; President and CEO: Hisashi Maruyama; hereinafter “Hitachi Chemical”) has completed its acquisition of apceth Biopharma GmbH (Head Office: Munich, Germany; CEO: Dr. Christine Guenther; hereinafter “apceth Biopharma”), a contract manufacturer of cell and gene therapy products, adding its ...
Allendale, NJ, United States, January 31, 2019 - Hitachi Chemical Advanced Therapeutics Solutions, LLC announces an agreement by which apceth Biopharma GmbH (“apceth Biopharma”), a contract manufacturer of cell and gene therapy products, will join Hitachi Chemical’s PCT global services platform. apceth Biopharma manufactures cell and gene therapy products for American and European clients through ...
Allendale, NJ, United States, January 29, 2019 - Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) announced it has successfully completed the technology transfer and implementation of the manufacturing process and commenced manufacturing services for dosing of patients in MaxCyte, Inc.’s Phase I dose-escalation clinical trial of MCY-M11 in the United States. MaxCyte MCY-M11, its ...
Munich, Germany, November 16, 2018 - apceth Biopharma GmbH, an established contract manufacturing organization in the field of gene and cell therapy, has started supplying clinical batches of DCprime’s cell-based cancer vaccine DCP-001 to a phase II clinical study for the treatment of Acute Myeloid Leukemia (AML). AML is a haematological cancer characterized by high risk of relapse, even after ...
Munich, Germany, Oct 5th, 2018 - apceth Biopharma GmbH, a leading company for the development and manufacturing of cell and gene therapeutics, congratulates its partner bluebird bio on the acceptance and validation of its market authorization application by the European Medicines Agency (EMA). bluebird bio has applied for market authorization of its investigational LentiGlobin™ gene therapy for ...
Allendale, NJ, United States, October 1, 2018 - Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) announced today that they have signed a three-year clinical manufacturing agreement with GSK, a science-led global healthcare company. Under the agreement, HCATS will manufacture GSK’s SPEAR T-cell receptor therapy targeting NY-ESO-1 for the US, Canadian and European trials. NY-ESO is ...