Tokyo /PRNewswire/ - FUJIFILM Corporation (President: Kenji Sukeno) has announced the selection of Holly Springs, North Carolina as the location for its new large-scale cell culture production site in the United States. The <a href="https://c212.net/c/link/?t=0&l=en&o=3102130-1&h=773966620&u=https%3A%2F%2Fwww.fujifilm.com%2Fus%2Fen%2Fnews%2FFujifilm_to_Invest_2B_for_Cell_Culture_Manufacturing_Site&a=previously+announced">previously announced</a> investment of more than 200 Billion yen (2 Billion USD) to establish the largest end-to-end cell culture biopharmaceutical CDMO1 facility in North America will create 725 highly-skilled jobs in the area by the end of 2028. FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, with development and manufacturing facilities across the United States, United Kingdom, and Denmark, will operate the new facility.
A rigorous data-driven evaluation process was followed to make the selection of Holly Springs, North Carolina as the home for the new facility. Holly Springs, North Carolina was selected for its strong pool of technical talent, local resources and partners with the right competencies, clean energy resources, and sustainability for future growth. With an existing facility in Morrisville, North Carolina, FUJIFILM Diosynth Biotechnologies is committed to continue its strong collaboration with state and local officials, which has been built over the years.
The new facility will offer large-scale cell culture manufacturing of bulk drug substance production with 8 x 20,000L bioreactors with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand. In addition, the facility will also provide commercial scale, automated fill-finish and assembly, packaging, and labelling services. The facility is expected to be operational by spring 2025.
The facility will be designed and built with sustainability as its core. The facility design targets 100% clean energy utilization, implementation of cutting edge waste disposal and recycling, among other sustainability goals.
&quot;Holly Springs, North Carolina is a suitable location for us, as it is one of the most active communities in the US in addressing environmental and social issues,&quot; said Kenji Sukeno, president of FUJIFILM Corporation. &quot;Fujifilm will contribute to realizing a sustainable society by collaborating with the Holly Springs community and stimulating the local economy, and further, by accelerating &quot;resolving social issues through business activities&quot; in alignment with our <a href="https://c212.net/c/link/?t=0&l=en&o=3102130-1&h=464550975&u=https%3A%2F%2Fholdings.fujifilm.com%2Fen%2Fsustainability%2Fplan%2Fsvp2030&a=Sustainable+Value+Plan+2030*.">Sustainable Value Plan 2030*.</a> And, the new site is strategically important to accelerate the growth of our Bio CDMO business.&quot;
&quot;We are passionate about the tremendous value that this new facility will bring to our partners in producing life-impacting therapies. To build what will be the largest end-to-end cell culture CDMO facility in North America requires commitment and partnership. We are delighted to have received the strong support from the town of Holly Springs and the state of North Carolina. This is building for the future, both in infrastructure and in talent, as part of the vibrant North Carolina biotech hub,&quot; said Martin Meeson, chief executive officer, FUJIFILM Diosynth Biotechnologies.
*Sustainable Value Plan 2030 is the company's Environmental, Social, and Governance (ESG) plan, targeting to be achieved by FY2031/Q3. It defines four key areas, namely the &quot;environment&quot;, &quot;health&quot;, &quot;daily life&quot; and &quot;work style&quot;, from the perspectives of &quot;considering environmental and social impacts through business processes&quot; and &quot;resolving social issues through business activities.&quot; For the area of the &quot;environment&quot;, the plan sets numerical targets including &quot;a 45% reduction in the volume of CO2 emitted across the entire product lifecycle compared to FY2014/Q3.&quot;
About Fujifilm 
 FUJIFILM Corporation is an operating company of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: <a href="http://www.fujifilmholdings.com/">www.fujifilmholdings.com</a>
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hiller&oslash;d, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway&trade; microbial and Apollo&trade;X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: <a href="http://www.fujifilmdiosynth.com/">www.fujifilmdiosynth.com</a>
All product and company names herein may be trademarks of their registered owners.
1 Contract Development and Manufacturing Organization
 Source: FUJIFILM Diosynth Biotechnologies 
Copyright 2021 PR Newswire. All Rights Reserved

United States of America

Fujifilm

Denmark

North America

North Carolina

Morrisville

Holly Springs

Kenji Sukeno

Tokyo /PRNewswire/ - FUJIFILM Corporation (President: Kenji Sukeno) has announced the selection of Holly Springs, North Carolina as the location for its new large-scale cell culture production site in the United States. The previously announced investment of more than 200 Billion yen (2 Billion USD) to establish the largest end-to-end cell culture

CDMO Fujifilm To Build New Biopharmaceutical Facility In North Carolina

The process of commissioning, qualification, and validation (CQV) sits on the critical path between a promising production line and commercial supply. Yet even in 2025, many life sciences companies still rely on binders of paper, wet‑ink signatures, and spreadsheets to prove that every asset performs as intended. Those manual steps can stretch sche

From Weeks to Minutes: How Intelligent Automation Transforms CQV Workflows

FDA announced on June 27, 2025, that Sandoz, Inc. is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial after customers complained that four penicillin G potassium for injection, USP, 20 million units labeled vials were incorrectly included in a carton of Cefazolin for Injection vials (1). While the company states it has

Sandoz Recalls Cefazolin Due to Mispackaging, Opens Biosimilar Facility in Slovenia

Piramal Pharma Solutions, the contract development and manufacturing organization within Mumbai-based Piramal Pharma, held a groundbreaking ceremony on June 25, 2025, for its new sterile injectables development and manufacturing facility in Lexington, Ky. (1). The new construction in Lexington, as well as in Riverview, Mich., comprise a $90 million

Piramal Pharma Breaks Ground on Kentucky Facility, Part of $90 Million Expansion Plan

Copyright © 2024 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy.
The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.
Copyright © 2024 Rodman Media. All rights reserved. Use of this constitutes acceptance o

t cell engager Archives

FDA Commissioner Marty Makary, M.D., M.P.H., tapped into his oncologist experience to launch a new FDA program designed to fast-track the time it takes for important drugs to receive approval and get to patients.
The Commissioner’s National Priority Voucher (CNPV) program allows drug developers to reduce review time from 10-12 months to 1-2 months

FDA Addresses U.S. Health Crisis With Voucher Program

GS1 US Barcode Assessment reveals that full UDI implementation is often impeded at the provider level.
Getty images. Credit: stevecoleimages
Key takeaways:
· The Barcode Assessment revealed that while most manufacturers are now labeling medical devices with barcodes containing the mandated Unique Device Identifier (UDI), healthcare providers aren’t

Bridging the Barcode Divide: Challenges in Medical Device UDI Implementation

Citation: Righton L, “Shortening and Decarbonising the Inhalation Supply Chain”. ONdrugDelivery, Issue 175 (Jul 2025), pp 26–29.
Louise Righton examines the potential for reducing emissions across the pMDI supply chain, considering the localisation of suppliers to shorten supply chains as well as strong partnerships for developing novel, low-carbon

SHORTENING AND DECARBONISING THE INHALATION SUPPLY CHAIN

Wednesday, July 02, 2025
Jazz Pharmaceuticals has received conditional marketing authorisation from the European Commission (EC) for Ziihera® (zanidatamab), a bispecific antibody targeting HER2, for the treatment of adults with unresectable locally advanced or metastatic HER2-positive biliary tract cancer (BTC) who have received at least one previo

Jazz Pharmaceuticals Receives Approval for Ziihera® for Advanced HER2-Positive Biliary Tract Cancer

ARTG Name
APX-VILDAGLIPTIN/METFORMIN 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film-coated tablet blister pack
Product name
APX-VILDAGLIPTIN/METFORMIN 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film-coated tablet blister pack
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
Arrotex Pharmaceuti

APX-VILDAGLIPTIN/METFORMIN 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film-coated tablet blister pack

US biotech Jazz Pharmaceuticals (Nasdaq: JAZZ) yesterday announced that the European Commission (EC) has granted conditional marketing authorization for Ziihera (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, with the news edging its shares up 3.1% to $109.44.
Ziihera is authorized as monotherapy

EC approves Jazz's Ziihera in biliary tract cancer

pharmsci Archives

Scientists at the University of Edinburgh’s Wallace Lab developed a method to produce paracetamol that can reduce environmental pollution and the industry’s reliance on fossil fuels.
Rather than using fossil fuels to produce paracetamol, the process converts terephthalic acid from polyethelene terephthalate (PET) into paracetamol with genetically e

Researchers Switch Up Paracetamol Production With Eco Method

Citation: “Interview with Brian Thompson and Dave Thoreson: Phillips Medisize Grows its Capabilities with Vectura”. ONdrugDelivery, Issue 175 (Jul 2025), pp 36–39.
In this exclusive interview with ONdrugDelivery’s Guy Furness, Brian Thompson and Dave Thoreson discuss Phillips Medisize’s expanded capabilities as a result of its recent acquisition of

Interview: Phillips Medisize Grows its Capabilities with Vectura

ARTG Name
ARX-VILDAGLIPTIN/METFORMIN 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film-coated tablet blister pack
Product name
ARX-VILDAGLIPTIN/METFORMIN 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film-coated tablet blister pack
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
Arrotex Pharmaceuti

ARX-VILDAGLIPTIN/METFORMIN 50/500 vildagliptin 50 mg/metformin hydrochloride 500 mg film-coated tablet blister pack

Philipp Richard scrutinises the efficient production of self-injection devices in the pharma industry and describes Ypsomed’s own platforms for developing these devices, highlighting the need to be adaptable and resilient to the rapidly evolving world of drug development. He provides valuable insights into the ways in which the flexible manufacture

Industrialising Drug Delivery175

ARTG Name
APO-VILDAGLIPTIN/METFORMIN 50/850 vildagliptin 50 mg/metformin hydrochloride 850 mg film-coated tablet blister pack
Product name
APO-VILDAGLIPTIN/METFORMIN 50/850 vildagliptin 50 mg/metformin hydrochloride 850 mg film-coated tablet blister pack
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
Arrotex Pharmaceuti

APO-VILDAGLIPTIN/METFORMIN 50/850 vildagliptin 50 mg/metformin hydrochloride 850 mg film-coated tablet blister pack

ARTG Name
APX-VILDAGLIPTIN/METFORMIN 50/1000 vildagliptin 50 mg/metformin hydrochloride 1000 mg film-coated tablet blister pack
Product name
APX-VILDAGLIPTIN/METFORMIN 50/1000 vildagliptin 50 mg/metformin hydrochloride 1000 mg film-coated tablet blister pack
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
Arrotex Pharmac

APX-VILDAGLIPTIN/METFORMIN 50/1000 vildagliptin 50 mg/metformin hydrochloride 1000 mg film-coated tablet blister pack

Through the partnership, CAI will deliver implementation services for ValGenesis’ AI-enabled platform, helping life sciences companies modernize their validation processes, reduce manual effort, and improve compliance outcomes. This collaboration aims to provide more efficient tech transfer across sites and programs, turning validation from a bottl

ValGenesis and CAI Partner to Advance AI-Enabled Digital Validation in Life Sciences

Behind the Headlines is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons

Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More

Simtra BioPharma Solutions, a contract development and manufacturing organization with facilities in Halle/Westfalen, Germany, and Bloomington, Ind., in the United States, said it has completed construction on a new production manufacturing building at its Germany campus (1). This expands the production area at that site by 1800 square meters (19,4

Simtra Completes Construction of New Production Facility in Germany

Frontage Holdings Corporation has appointed Dr. Abdul Mutlib as the President of Frontage Laboratories, Canada. Mutlib will spearhead Frontage’s growth in the Canadian market and continue to serve as the Chief Scientific & Strategy Officer for Frontage Laboratories.
This appointment reflects Frontage’s commitment to enhancing and expanding its serv

Frontage Expands Business in Canada with New Leadership

Contract development and manufacturing organization (CDMO) WuXi XDC Cayman announced the mechanical completion of its bioconjugates manufacturing site at Tuas Biomedical Park in Singapore. The 25,000 square-meter site will transition into the commissioning and qualification (C&Q) stage.
Construction of the facility began in March 2024, and with its

WuXi XDC completes construction of Singapore bioconjugation site

The biotech industry is often described in grand dichotomies such as innovator vs. generic, small molecule vs. large molecule, or clinical vs. commercial.
These and other differentiators influence development and manufacturing, the selection of CDMOs, and outsourcing strategies.
My colleague at Advancing RNA, Chief Editor Anna Rose Welch, recently

RNAi vs. mRNA: Two Therapies, Two CDMO Strategies

By Andrew Walsh; Thomas Altmann; Joshua Anthes; Ralph Basile; Alfredo Canhoto, Ph.D.; Stéphane Cousin; Hyrum Davis; Parth Desai; Boopathy Dhanapal, Ph.D.; Jayen Diyora; Igor Gorsky; Benjamin Grosjean; Richard Hall Hall; Ovais Mohammad; Mariann Neverovitch; Rod Parker; Miquel Romero-Obon; Jeffrey Rufner; Siegfried Schmitt, Ph.D.; Osamu Shirokizawa;

Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

Wednesday, August 13, 2025, 1:00 PM - 1:30 PM (UTC-04:00) Eastern Time (US & Canada)
Join us for an in-depth conversation with Ullrich Mayeski, J.D., Director of Community Engagement, Healthcare, GS1 US. We will explore how technologies like 2D barcodes are transforming supply chain visibility and transparency—especially in the pharmaceutical space