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, fomerly PCT or PCT Cell Therapy Services), apceth Biopharma GmbH, and Hitachi Chemical Co., Ltd. have been renamed Minaris Regenerative Medicine and are part of the Resonac Group.
October 2, 2024

Minaris Regenerative Medicine and TFBS Announce Strategic Partnership to Advance Cell and Gene Therapy

Allendale, NJ, USA and Taipei, Taiwan – October 2, 2024 Minaris Regenerative Medicine, LLC (Minaris) and TFBS Bioscience Inc. (TFBS) are pleased to announce a strategic partnership in cell and gene therapy (CGT) mainly in North America. This collaboration is designed to enhance their capabilities to drive industry innovation by providing the one-stop-shop solutions. The strategic partnership ...

September 24, 2024

Minaris Regenerative Medicine Announces Agreement to be Acquired by Altaris (Japanese)

Yokohama, Japan, Munich, Germany, and Allendale, New Jersey, USA. September 24, 2024. 2024年9月24日 Minaris Regeneraive Medicine株式会社 代表取締役社長 坂東 博人 Minarisグループに関する株式譲渡契約締結について  本日2024年9月24日付にて株式会社レゾナック・ホールディングスの連結子会社である株式会社レゾナックは、Minaris Regenerative Medicine株式会社、Minaris Regenerative Medicine, LLC(アメリカ)、及びMinaris Regenerative Medicine GmbH(ドイツ)(以下、3社を総称してMinarisグループ、取締役兼CEO坂東 ...

September 24, 2024

Minaris Regenerative Medicine Announces Agreement to be Acquired by Altaris (English)

Yokohama, Japan, Munich, Germany, and Allendale, New Jersey, USA. September 24, 2024. Minaris Regenerative Medicine (“Minaris”), a leading cell therapy contract development and manufacturing organization, is pleased to announce that its parent company, Resonac Corporation (“Resonac”), has entered into a definitive agreement to sell Minaris to a fund managed by Altaris, LLC (collectively with its ...

September 24, 2024

Minaris Regenerative Medicine kündigt Vereinbarung zur Übernahme durch Altaris an (Germany)

Yokohama, Japan, München, Deutschland und Allendale, New Jersey, USA. 24. September 2024. Minaris Regenerative Medicine (Minaris), ein führendes Auftragsentwicklungs- und Herstellungsunternehmen (CDMO) für Zelltherapien, freut sich bekanntzugeben, dass seine Mutterfirma, Resonac Corporation („Resonac“), eine endgültige Vereinbarung abgeschlossen hat über den Verkauf von Minaris an einen Fond, der ...

September 11, 2024

Adopted for NEDO Program (Japanese)

Yokohama, Japan - September 12th, 2024 - We are pleased to inform you that Minaris Regenerative Medicine Co., Ltd. has been selected for the project publicly solicited by the Japanese organization New Energy and Industrial Technology Development Organization (NEDO). Details in Japanese for local news in Japan.  ...

August 20, 2024

Business alliance with CellTech (English)

Taipei, Taiwan, and Yokohama, Japan - August 21st, 2024 - Celltech Innovation Venture Studio Co., Ltd. (“CellTech Accelerator”), the first cell and gene therapy accelerator in Asia, and Minaris Regenerative Medicine Co., Ltd. ("Minaris"), a global contract development and manufacturing organization for cell and gene therapies, today announced a strategic partnership to accelerate the ...

August 20, 2024

Business alliance with CellTech (Japanese)

Taipei, Taiwan, and Yokohama, Japan - August 21st, 2024 - We are pleased to inform you that Minaris Regenerative Medicine Co., Ltd. and Cell tech Innovation Venture Studio Co., Ltd. have entered into a business alliance. Details in Japanese for local news in Japan.  Celltech Innovation Venture Studio Co., Ltd.(本社:台北、Founder & Chairman Johnny Yu、以下CellTech Accelerator)とMinaris Regenerative ...

June 24, 2024

Business alliance with Cryoport (English)

NASHVILLE, Tenn., USA, and Yokohama, Japan - June 20th, 2024 - Cryoport, Inc. (NASDAQ: CYRX) (“Cryoport”), a global leader in supply chain solutions for the life sciences, and Minaris Regenerative Medicine Co., Ltd. ("Minaris"), a global contract development and manufacturing organization for cell and gene therapies, today announced a strategic partnership to provide fully integrated logistics ...

June 19, 2024

Business alliance with Cryoport (Japanese)

Yokohama, Japan - June 20th, 2024 - We are pleased to inform you that Minaris Regenerative Medicine Co., Ltd. and Cryoport, Inc. have entered into a business alliance. Details in Japanese for local news in Japan.    Cryoport, Inc.(本社:テネシー州、CEO Jerrell W. Shelton、以下 Cryoport)とMinaris Regenerative Medicine株式会社(本社:神奈川県横浜市、代表取締役社長 坂東 博人、以下 Minaris)は、再生医療等製品の輸送に関する業務提携契約を締結しました。  ...

June 13, 2024

Minaris Regenerative Medicine Implements Manufacturing Execution System Werum PAS-X MES

Lüneburg and Ottobrunn, Germany, June 13, 2024 – Minaris Regenerative Medicine GmbH (Minaris), a leading contract development and manufacturing organization for cell and gene therapies, has implemented a digital Manufacturing Execution System (MES), the newest version of Werum PAS-X MES by Körber, at its German site in Ottobrunn near Munich. By doing so, Minaris is converting its production ...

June 3, 2024

Business alliance with Myoridge (Japanese)

Yokohama, Japan - June 4th, 2024 - We are pleased to inform you that Minaris Regenerative Medicine Co., Ltd. and Myoridge Co., Ltd. have entered into a business alliance. Details in Japanese for local news in Japan.  株式会社マイオリッジ(本社:京都府京都市、代表取締役社長 牧田 直大、以下マイオリッジ)とMinaris Regenerative Medicine株式会社(本社:神奈川県横浜市、代表取締役社長 坂東 博人、以下 Minaris)は、培地最適化による再生医療等製品の製造プロセス開発支援に関する業務提携契約を締結しました。   ...

May 8, 2024

First Commercial Cell and Gene Therapy Product Manufactured at Minaris Regenerative Medicine in Allendale, NJ.

With the recent FDA approval of LYFGENIA™, developed by bluebird bio, Minaris Regenerative Medicine North America is now supporting a commercial cell and gene therapy (CGT) product. The first commercial drug product was manufactured in early May. This confirms the capability of Minaris Regenerative Medicine as a commercial manufacturing CDMO. Allendale, NJ, USA, Wednesday 08 May 2024 – Minaris ...

March 14, 2024

Business alliance with VectorBuilder Inc. (Japanese)

Yokohama, Japan - March 14th, 2024 - We are pleased to inform you that Minaris Regenerative Medicine Co., Ltd. and VectorBuilder Inc. have entered into a business alliance. Details in Japanese for local news in Japan.  Minaris Regenerative Medicine株式会社(本社:神奈川県横浜市、代表取締役社長 坂東 博人、以下 Minaris)は、VectorBuilder Inc.(本社:Chicago, IL 60609, USA、最高科学責任者 Bruce Lahn, Ph.D.、以下 VectorBuilder)と業務提携を結んだことをお知らせします。 ...

March 7, 2024

Hiroto Bando Appointed CEO of Minaris Regenerative Medicine GmbH (Germany)

Munich, Germany - November 28th, 2023 - Minaris Regenerative Medicine GmbH, a leading contract development and manufacturing organization (CDMO) for the cell and gene therapy industry fully owned by Resonac Group, announces the appointment of Hiroto Bando, PhD as CEO of the European operations of Minaris Regenerative Medicine (Minaris) as of November 28, 2023. Hiroto Bando assumes this new role ...

September 6, 2023

Minaris Regenerative Medicine Selects Apprentice.io’s Tempo Manufacturing Execution System to Scale Commercial Production

JERSEY CITY, N.J. - September 6th, 2023 - Apprentice.io, leading technology provider for life sciences manufactures, announced that Minaris Regenerative Medicine, a leading contract development and manufacturing organization (CDMO) focused on cell and gene therapies, has selected Apprentice’s Tempo Manufacturing Execution System (MES) to digitize its commercial manufacturing in North America and ...

May 24, 2023

Minaris Regenerative Medicine Streamlining Contract Manufacturing with Veeva Vault Quality Suite Applications

Pleasanton, CA - May 24, 2023 - Veeva Systems (NYSE: VEEV) today announced that Minaris Regenerative Medicine, a leading contract development and manufacturing organization (CDMO) focused on cell and gene therapies, selected Veeva Vault QualityDocs and Veeva Vault Training to advance its global quality operations. Minaris Regenerative Medicine will use Veeva’s unified quality applications to ...

February 16, 2023

LIfT BioSciences and Minaris Regenerative Medicine Enter into a Development and Manufacturing Partnership for N-LIfT Allogeneic Neutrophil Based Cell Therapy

LONDON, UK and MUNICH, GERMANY - February 16, 2023 - LIfT BioSciences, a pioneering pre-clinical stage company moving into first-in-human trials with an allogeneic neutrophil progenitor based cell therapy, and Minaris Regenerative Medicine GmbH, a leading global contract development and manufacturing service provider for the cell and gene therapy industry, have entered into a development and ...

December 7, 2022

Minaris appoints Dr Helmut Lerch as Global Quality Head

MUNICH, GERMANY - December 7, 2022 - Minaris Regenerative Medicine is pleased to announce that, effective December 1, 2022, Helmut Lerch, PhD, who joined the company in July of this year as Head, Quality Management for Minaris Regenerative Medicine GmbH (the company’s Germany region) will assume the role of Global Quality Head, succeeding Jacqueline Veivia-Panter. Helmut is an accomplished ...

October 28, 2022

Minaris Regenerative Medicine GmbH and Mendus AB extend manufacturing partnership to large-scale production of DCP-001, an experimental allogeneic cell-based immunotherapy addressing tumor recurrence

Munich, Germany, and Stockholm, Sweden - Oct 28, 2022. Mendus AB (“Mendus publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence and Minaris Regenerative Medicine GmbH („Minaris“), a leading contract development and manufacturing service provider for the cell and gene therapy industry, have extended their manufacturing partnership for technology ...

October 13, 2022

Showa Denko Materials and Kidswell Bio Enter Into an Agreement for Process Development and Clinical Manufacturing of Cell Therapy Products

Tokyo, Japan - October 13, 2022. Showa Denko Materials Co., Ltd. (Head office: Chiyoda-ku, Tokyo; President and CEO: Hidehito Takahashi; hereinafter “Showa Denko Materials”) and Kidswell Bio Corporation (Head office: Chuo-ku, Tokyo; President and CEO: Masaharu Tani; hereinafter “Kidswell Bio”) entered into an agreement to enable process development as well as clinical manufacturing...

October 12, 2022

Cellusion and Minaris Regenerative Medicine, a member of Showa Denko Materials, Enter into Business Alliance for the Manufacturing of CLS001 for a Corneal Endothelial Cell Regenerative Therapy

Allendale, NJ, USA and Yokohama, Japan - October 12, 2022 - Cellusion Inc. (CEO: Shin Hatou, M.D. Ph.D., “Cellusion”), a Japanese regenerative medicine startup aiming to solve the global corneal transplant waiting list problem with a unique differentiation induction method from iPS cells to Corneal Endothelial Cell Substitute from iPS Cells (CECSi Cells) for bullous keratopathy novel treatment...

June 27, 2022

Ixaka and Minaris Regenerative Medicine Sign Tech Transfer and GMP Manufacturing Agreement for Lead Cell Therapy Candidate REX-001

London, UK and Munich, Germany - June 27, 2022 - Ixaka Ltd Minaris Regenerative Medicine GmbH today announced that they have signed an agreement to enable technology transfer as well as clinical and commercial manufacture of REX-001.

December 20, 2021

Minaris Regenerative Medicine Appoints Hiroto Bando as New General Manager

Allendale, N.J., USA and Yokohama, Japan - Dec. 20, 2021 - Minaris Regenerative Medicine is pleased to announce new appointments to strengthen its global and regional leadership. Hiroto Bando, PhD, who joined Minaris Regenerative Medicine as Deputy General Manager.

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. In her role as head of business development for North America, reporting to CEO, Dr. Kazuchika Furuishi, Emmanuelle will be accountable for creating new business opportunities and client management for ...

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. Minaris Regenerative Medicine, having facilities in the U.S., Germany, and Japan, will shift to a model of regional operational leadership on October 1, 2021. Under the new model, its three regional Chief ...

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. Dusan Kosijer has served as Chief Financial Officer of ...

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. European Facility Expansion: A new state ...

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. At this time, our facilities continue operations and all our amazing employees are working exceptionally hard through these challenging circumstances to provide our clients with the high-quality support they are accustomed to and deserve. Although both Bergen County, New Jersey and Santa ...

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. And now the future ...

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 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

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. apceth Biopharma manufactures cell and gene therapy products for American and European clients through ...

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. MaxCyte MCY-M11, its ...

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. Brian Hanifin will fill the role of Interim Head of Technical Operations for HCATS. Brian has 25+ years of extensive pharmaceutical experience leading internal company plants. He has been an ...

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

Leiden, The Netherlands, and Munich, Germany, October 19, 2017 - DCPrime BV, a clinical stage company developing dendritic cell vaccines to treat cancer, and apceth Biopharma GmbH, an established contract manufacturing organization in the field of gene and cell therapy, report today that they have entered into a strategic manufacturing agreement. The collaboration involves clinical batch ...

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 includes ...

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. PCT is a leading provider of contract services ...

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. To date, PCT has provided engineering and process development services for ...

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. Offering an approach to cell therapy manufacturing grounded in Development by Design ...

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 New York, NY, December 3, 2013-- NeoStem, Inc. (Nasdaq:NBS), and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), announced the expansion of PCT’s relationship with ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT:IMUC), a clinical-stage company that is developing immune-based ...

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 ...