News

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.

*This page may include mention of our past company names as it reflects content distributed in the past. The former companies Hitachi Chemical Advanced Therapeutics Solutions (HCATS, formerly PCT or PCT Cell Therapy Services) and apceth Biopharma GmBH are now operating under the name Minaris Regenerative Medicine. Hitachi Chemical Co., Ltd. has been renamed Showa Denko Materials Co., Ltd.
September 9, 2021

Welcome Emmanuelle Bommier, Senior Director, Business Development, to Minaris Regenerative Medicine (United States)

ALLENDALE, NJ - September 9, 2021 - Minaris Regenerative Medicine (United States) welcomes Emmanuelle Bommier in the role of Senior Director, Business Development, effective August 30, 2021.

July 21, 2021

Minaris will be the commercial manufacturer in Europe for Skysona™, bluebird bio's gene therapy for CALD

MUNICH, Germany – July 21, 2021 - Minaris Regenerative Medicine GmbH (“Minaris”), a leading contract development and manufacturing organization (CDMO) for the cell and gene therapy industry, will be the commercial manufacturer in Europe for SkysonaTM (elivaldogene autotemcel, Lenti-D™), a product of bluebird bio, Inc. Today, the European Commission (EC) has granted marketing authorization for ...

June 28, 2021

Minaris Regenerative Medicine Strengthens Global and Regional Leadership

ALLENDALE, NJ., USA, MUNICH, GERMANY, and YOKOHAMA, JAPAN – June 28, 2021— Minaris Regenerative Medicine is pleased to announce new appointments to strengthen its global and regional leadership.

February 22, 2021

MaxiVAX and Minaris Regenerative Medicine Enter into a Manufacturing Partnership for MVX-ONCO-2 Cancer Immunotherapy

GENEVA, Switzerland and MUNICH, Germany – Feb 22, 2021 —MaxiVAX SA, a private Swiss clinical-stage biotech company developing novel anti-cancer vaccines, and Minaris Regenerative Medicine GmbH (“Minaris”), a leading contract development and manufacturing service provider for the cell and gene therapy industry, have entered into a manufacturing agreement for MVX-ONCO-2, a cell-based immunotherapy ...

January 25, 2021

Dusan Kosijer apppointed CEO of Minaris Regenerative Medicine GmbH

MUNICH, Germany – January 25, 2021- Minaris Regenerative Medicine GmbH, a leading contract development and manufacturing organization (CDMO) for the cell and gene therapy industry fully owned by Showa Denko Materials Co., Ltd., announces the appointment of Dusan Kosijer as CEO of the European operations of Minaris as of January 1, 2021.

November 23, 2020

Mustang Bio and Minaris Regenerative Medicine Sign Technology Transfer and GMP Manufacturing Agreement for MB-107 Lentiviral Gene Therapy for X-Linked Severe Combined Immunodeficiency

WORCESTER, Mass. and MUNICH, Germany– Nov 23, 2020 — Mustang Bio, Inc. (“Mustang”) (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, and Minaris Regenerative Medicine GmbH (“Minaris”), a leading contract development and ...

November 2, 2020

Minaris Regenerative Medicine to Significantly Expand Manufacturing Capacity for Cell and Gene Therapies in Germany and Japan

Munich, Germany and Yokohama, Japan – Nov. 2, 2020 — Minaris Regenerative Medicine (“Minaris”), a leading global contract development and manufacturing organization for cell and gene therapies, wholly owned by Showa Denko Materials Co., Ltd., announced today a total investment of 64.5 million USD to significantly expand its facilities in Europe and Asia.

September 23, 2020

Hitachi Chemical's Global Regenerative Medicine Business Renamed Minaris Regenerative Medicine

Allendale, NJ., USA, Munich, Germany, and Yokohama, Japan-Sept. 23, 2020-The regenerative medicine business of Hitachi Chemical Co., Ltd. (“Hitachi Chemical”) announces that, effective today, it has adopted the name Minaris Regenerative Medicine to represent its global contract development and manufacturing services business for the cell and gene therapy industry. “By working and using the single ...

May 11, 2020

Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma GmbH Enter into Strategic Clinical and Commercial Manufacturing Agreements with bluebird bio

 ALLENDALE, NJ. and MUNICH, GERMANY.-- May 11, 2020-- Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS) and apceth Biopharma GmbH (apceth), both subsidiaries of Hitachi Chemical Co., Ltd. (Hitachi Chemical), today announced that they have expanded their relationship with bluebird bio (NASDAQ: BLUE) with long-term development and manufacturing services agreements for clinical and ...

April 10, 2020

Continuing to Navigate COVID-19 Together

The entire team at HCATS continues its commitment to stay ahead of and respond to the COVID-19 situation.

March 18, 2020

Navigating COVID-19 at HCATS

At HCATS, we are dedicated to providing our clients with high value development and manufacturing services while fostering a safe environment that does not put our patients, clients, or employees at risk. Due to this and the growing concern of COVID-19, we are taking necessary precautions and implementing new policies and procedures so we can continue to work toward making transformative ...

January 30, 2020

Hitachi Chemical Opens New Cell and Gene Therapy Manufacturing Facility

Company Expects to Add Up to 500 Employees in New Jersey Hitachi Chemical Advanced Therapeutics Solutions, LLC (“HCATS”), a subsidiary of Hitachi Chemical Co., Ltd. representing Hitachi Chemical’s Regenerative Medicine Business Sector (“RMBS”) in North America, today announced the opening of its new cell and gene therapy manufacturing facility in Allendale, New Jersey. The new facility is the ...

January 21, 2020

Announcing Our Joint Development Agreement With Ori Biotech

For 20 years, Hitachi Chemical Advanced Therapeutics Solutions (HCATS) has helped clients to improve their cell-based therapy development and manufacturing processes. The client-focused mindset of our PCT global service platform allows our team to easily facilitate technology transfers, accelerate time to market, and reduce the costs and risks of clinical development programs.

January 13, 2020

apceth Starts Commercial Manufacturing of Zynteglo, bluebird bio's gene therapy for transfusion-dependent B-thalassemia

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 ...

June 4, 2019

apceth Will Operate as the Commercial Manufacturer in Europe for Zynteglo, bluebird bio’s Gene Therapy for β-thalassemia

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 and Saint-Gobain Announce Collaboration to Co-Develop and Commercialize Cell Therapy Manufacturing Technology

 

April 3, 2019

Hitachi Chemical Co. Ltd. Completes Acquisition of apceth Biopharma GmbH, Expanding Global Footprint of its Cell and Gene Therapy Contract Development and Manufacturing Services

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 ...

January 31, 2019

Hitachi Chemical Co. Ltd. to Acquire apceth Biopharma GmbH, Expanding Global Footprint of its Cell and Gene Therapy Contract Development and Manufacturing

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.

January 29, 2019

Hitachi Chemical Advanced Therapeutics Solutions Completes Technology Transfer to Enable Manufacturing of MaxCyte’s CARMA™ Cell Therapy for Clinical Use

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.

November 16, 2018

apceth Biopharma GmbH Manufactures DCprime’s Cell-Based Cancer Vaccine for Phase II Clinical Study

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 ...

October 5, 2018

apceth to Manufacture First Potential One-Time Gene Therapy for Transfusion Depended β-thalassemia

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 ...

October 1, 2018

Hitachi Chemical Advanced Therapeutics Solutions Signs Three-Year Agreement with GSK

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 ...

September 25, 2018

Hitachi Chemical Advanced Therapeutics Solutions and Rutgers University - New Brunswick Announce Collaboration on Graduate-Level Bioengineering Course

  NEW BRUNSWICK, NJ – Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS), a U.S. subsidiary of Hitachi Chemical Co. Ltd. that engages in contract manufacturing and development of regenerative medicine products, and Rutgers University–New Brunswick’s School of Engineering today announced a collaboration to launch a graduate-level course, “Integrative Molecular and Cellular ...

September 24, 2018

Announcing Transition for the Role of Chief Operating Office of HCATS

After three years of operations leadership for Hitachi Chemical Advanced Therapeutics Solutions (HCATS), William (Bill) Monteith will be leaving HCATS with transition expected to complete by November 2018.

March 19, 2018

Hitachi Chemical Signed Agreement for Clinical Manufacturing of Regenerative Medicine with Daiichi Sankyo

March 19, 2018 - Hitachi Chemical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President and CEO: Hisashi Maruyama; hereinafter “Hitachi Chemical”) announces the signing of an agreement with Daiichi Sankyo Co., Ltd. (Head Office: Chuo-ku, Tokyo; hereinafter “Daiichi Sankyo”) for clinical manufacturing*1 of Regenerative Medicine developed by Daiichi Sankyo for the Japanese market. Hitachi Chemical ...

March 13, 2018

SanBio Reaches Agreement on Manufacture of Regenerative Medicine Product SB623 with Hitachi Chemical

Tokyo, Japan, March 13, 2018—SanBio Group and Hitachi Chemical Co., Ltd. (Hitachi Chemical) jointly announced today that, through an agreement with Hitachi Chemical Advanced Therapeutics Solutions, LCC (HCATS; formerly PCT Cell Therapy Services, LLC), Hitachi Chemical’s U.S. subsidiary that engages in contract manufacturing and development of regenerative medicine products1, they will manufacture ...

February 13, 2018

Construction Begins to Expand PCT's Services: GMP Manufacturing Infrastructure and Cleanroom Capacity to Support Clients through Commercial Stage

We at Hitachi Chemical Advanced Therapeutics Solutions, LLC are excited to announce that construction on additional PCT GMP manufacturing infrastructure and cleanroom capacity has begun at our newly-leased 49,700 square foot facility in Allendale, New Jersey (“75 Commerce”) in addition to upgrades to our existing facility at 4 Pearl Court, Allendale (“4 Pearl Court”). The upgrades will allow us ...

October 19, 2017

DCPrime and apceth Biopharma GmbH Announce Manufacturing Partnership

                                                                     

October 19, 2017

PCT Establishes Global Contract Development and Manufacturing Services Platform with Opening of Yokohama, Japan Facility

Yokohama, Japan, October 19, 2017: Hitachi Chemical Co., Ltd. (HCC), a global service provider for the cell therapy industry through its PCT development and manufacturing service platform, today announced the completion of construction and opening of its Yokohama, Japan facility on October 11. This facility, as well as the existing two U.S. PCT facilities, will share the same global PCT service ...

October 10, 2017

PCT GMP Manufacturing Infrastructure and Cleanroom Capacity Expands to Support Clients through Commercial Stage

Allendale, NJ, USA, October 10, 2017   Today, Hitachi Chemical Advanced Therapeutics Solutions, LLC (HCATS), a global service provider for the cell therapy industry through its PCT development and manufacturing platform, announced the planned expansion of its PCT service platform through the addition of GMP manufacturing infrastructure and cleanroom capacity in Allendale, NJ. The expansion ...

May 31, 2017

Orchard Therapeutics Ltd. Announces a Manufacturing Services Agreement with PCT Cell Therapy Services, LLC

Orchard Therapeutics Limited (“Orchard”), a clinical-stage biotechnology company dedicated to bringing transformative ex-vivo gene therapies to patients with rare diseases of high unmet medical need announces today that it has entered a new clinical manufacturing services agreement with PCT Cell Therapy Services, LLC (“PCT”), a Hitachi Group Company.

March 16, 2017

Hitachi Chemical Co. America, Ltd. to Acquire 100% of PCT - A Transformative Event for PCT and Hitachi Chemical

We are pleased today to announce a significant upcoming transformation for our company and enhancements to our capabilities to serve our valued clients. Hitachi Chemical Co. America, Ltd. (Hitachi Chemical), our collaborator and currently minority owner of PCT, has entered into an agreement with Caladrius Biosciences, majority owner of PCT, to purchase Caladrius’ remaining share of PCT, with an ...

June 29, 2016

Blood Cell Research Collaboration by PCT and Harvard Scientists

CD34+ CD45- Cells Isolated from Human Blood Have Molecular and Functional Characteristics of Vascular Endothelial Progenitors Rare CD45- cells have been described in human blood, bone marrow and umbilical cord blood that lack blood cell lineage markers (Lin-) but express antigens (CD34 and/or CD133) associated with hematopoietic (blood cell) progenitors.  This is in contrast to typical ...

June 27, 2016

President of PCT, Robert Preti, PhD, Named Chairman of the Alliance for Regenerative Medicine

PCT announces that Robert A. Preti, Ph.D., the Company’s Chief Technology Officer, President of PCT,  has been named Chairman of the Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the gene and cell therapies and broader regenerative medicine sector. Dr. Preti has served as Vice Chairman of ARM since January 2015 and succeeds Edward Lanphier as ...

June 21, 2016

PCT to Manufacture Phase 3 Cell Therapy Product for Kiadis Pharma

PCT has expanded its relationship with Kiadis Pharma (Euronext Amsterdam and Brussels: KDS) (“Kiadis”), by entering into an agreement for the manufacturing of cell therapy product for United States and Canada clinical trial sites for a Phase 3 trial of Kiadis’ lead product, ATIR101™, for the treatment of blood cancers.

January 13, 2016

Getting Commercial: Engineering the Future at Phacilitate Cell and Gene Therapy World Conference

PCT leaders will offer their perspective on cell therapy manufacturing of the future at this month’s Phacilitate Cell and Gene Therapy World conference. Through presentations and an interactive panel discussion, PCT will outline the framework that enables successful product commercialization over the long-term.

September 8, 2015

PCT, LLC, A Caladrius Company, to Manufacture EU-Compliant Cell Therapy Product for IRX Therapeutics, Inc. From Its New Jersey Facility

ALLENDALE, N.J., Sept. 8, 2015 -- PCT, LLC, A Caladrius Company (PCT), the manufacturing sciences and technical operations subsidiary of cell therapy leader Caladrius Biosciences (NASDAQ:CLBS) and leading external manufacturing partner to the cell therapy industry, announced today that it will expand its current manufacturing capacity at PCT's Allendale, New Jersey facility to support IRX ...

June 15, 2015

PCT, a Caladrius Company, Expands Relationship With ImmunoCellular Therapeutics to Provide Manufacturing For Their Phase 3 Trial

New York (June 15, 2015) – Caladrius Biosciences, Inc. (Nasdaq:CLBS) (“Caladrius”), a cell therapy leader with a late-stage clinical program for immuno-oncology, announced today a new Agreement between its wholly-owned subsidiary, PCT, LLC, a Caladrius Company (“PCT”), and ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT:IMUC), a clinical-stage company that is developing ...

April 30, 2014

PCT Enters Into a Services Agreement With IRX Therapeutics, Inc.

New York, N.Y. April 30, 2014 -- NeoStem, Inc. (NASDAQ:NBS) and its subsidiary, Progenitor Cell Therapy, LLC (“PCT”), announced the execution of a Services Agreement with IRX Therapeutics, Inc. (“IRX”) under which PCT will provide services to support IRX’s development of IRX-2, a primary cell-derived biologic with multiple active cytokine components. IRX-2 is a cancer therapeutic designed to ...

March 10, 2014

Progenitor Cell Therapy (PCT), Announces Bi-coastal Facility Expansions

March 10, 2014 — NeoStem, Inc. (NASDAQ:NBS) (“NeoStem” or the “Company”), a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC (“PCT”), an internationally recognized contract development and manufacturing organization, announced today that PCT has expanded both its Allendale, NJ and Mountain View, CA current Good Manufacturing Practice (“cGMP”) ...

January 13, 2014

Progenitor Cell Therapy (PCT), to Present at Five Sessions at the 2014 Phacilitate Cell & Gene Therapy Forum

New York, Jan. 13, 2014 -- NeoStem, Inc. (Nasdaq:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized contract development and manufacturing organization, announced today that NeoStem and PCT will present at five sessions at the Phacilitate Cell & Gene Therapy Forum 2014 ...

January 9, 2014

NeoStem's Subsidiary, Progenitor Cell Therapy (PCT), to Provide Process Development and Manufacturing Services to Kite Pharma

Services Will Utilize Additional Clean Room Capacity Recently Added to PCT's California Facility NEW YORK, Jan. 9, 2014 (GLOBE NEWSWIRE) -- NeoStem, Inc. (Nasdaq:NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), announced today the execution of a Services Agreement with Kite Pharma, Inc., under which PCT will provide cell therapy process development and manufacturing services for ...

December 3, 2013

Progenitor Cell Therapy LLC (“PCT”), Expands Manufacturing Relationship with ImmunoCellular Therapeutics for Dendritic Cell Vaccines

New Process Development Improvements Intended to Ensure Phase 3 and Commercial Readiness for Client

January 16, 2013

NeoStem's Subsidiary, Progenitor Cell Therapy, Enters Into a Cell Therapy Manufacturing Services Agreement With Adaptimmune

PCT to Provide Cell Product Development and Manufacturing for Adaptimmune's Clinical Trials Allendale, N.J. and Oxford, United Kingdom, Jan. 16, 2013 -- NeoStem, Inc. (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy LLC ("PCT"), together with Adaptimmune Limited and Adaptimmune LLC (collectively, "Adaptimmune"), announced today a Services Agreement under which PCT will provide services ...

January 7, 2013

Progenitor Cell Therapy, and Hackensack University Medical Center Enter Into a Cell Processing and Storage Services Agreement

Allendale, N.J. and Hackensack, N.J., Jan. 7, 2013 -- NeoStem, Inc. (NYSE MKT:NBS) and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized contract development and manufacturing organization (CDMO), and Hackensack University Medical Center ("HackensackUMC"), part of the Hackensack University Health Network and a hub of healthcare for the Northern New Jersey and New ...