AGC Biologics Partners with Novelty Nobility for Cell Line Development and Phase I Preparations of Antibody Drug Candidate
COPENHAGEN, Denmark & CHIBA, Japan--(BUSINESS WIRE)-- AGC Biologics, your friendly CDMO expert, today announced a multiphase partnership with Novelty Nobility Inc., a clinical-stage biotech company based in South Korea. Novelty Nobility will leverage AGC Biologics' expertise and proprietary CHEF1® expression technology for cell line development and prepare for Phase I clinical trials via a multi-site partnership with AGC Biologics' Copenhagen, Denmark and Chiba, Japan facilities.
When clients work with us, they tap into our entire global network – we find the right expertise wherever it exists and bring teams together for a seamless experience, no matter where the work is being done.
Share
Novelty Nobility develops innovative antibody drugs, including bispecific antibodies and antibody-drug conjugates (ADCs). The company is currently developing two clinical assets in the United States in immunology and oncology, respectively.
AGC Biologics will develop the cell line and create a master cell bank (MCB) for Novelty Nobility's first-in-class bispecific antibody drug candidate at its Copenhagen facility. After the MCB is created, the second phase of the partnership will focus on expanded process development work and GMP manufacturing preparation at the AGC Biologics Chiba site. The first stage of the project began in March.
"We are very happy with the partnership with Novelty Nobility, where we will apply our CHEF1 platform to a novel bispecific antibody, helping support the advancement of this important candidate towards clinical trials," said Kasper Møller, Chief Technical Officer and Executive Vice President, AGC Biologics. "Our cell line development expertise in Copenhagen is strategically aligned with Novelty Nobility's objectives, and we believe we can provide a strong foundation for their therapeutic development program."
"Chiba's partnership with our Copenhagen team gives Novelty Nobility access to world-class cell line development experts while keeping their regional connection strong," noted Susumu Zen-in, Senior Vice President and General Manager, AGC Biologics Chiba. "When clients work with us, they tap into our entire global network – we find the right expertise wherever it exists and bring teams together for a seamless experience, no matter where the work is being done. This approach is already helping us throughout the APAC region and creating wins for both Novelty Nobility and AGC Biologics."
AGC Biologics' CHEF1 expression technology is a proven platform for cell line development, with a track record of producing stable cell lines for a variety of biologics. With five commercial products on the market and 54 distinct molecules developed, the platform delivers a reliable and efficient path to success. The cell line platform excels in handling complex molecules, providing solutions for challenging biologics that require specialized expression systems. The CHEF1 platform is also royalty-free, eliminating additional costs for clients as their products advance through clinical phases toward commercialization.
AGC Biologics offers a comprehensive suite of services for mammalian-based drug production, from cell line development to commercial manufacturing, enabling partners to accelerate their drug development timelines and bring life-changing therapies to patients. Visit www.agcbio.com/capabilities/mammalian to learn more.
About Novelty Nobility Inc.
Novelty Nobility is a clinical stage biotechnology company developing fit-for-purpose antibodies to deliver meaningful therapeutic benefits to patients. Starting with the end in mind, the Company is crafting tailored solutions by matching the right antibody modality to the underlying mechanisms of a specific disease. While this 'good' antibody approach can be used in many treatments, this versatility isn't automatic—it is supported by our design-driven antibody discovery platform, PREXISE®-D, to ensure the best results for each application.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,800 Team Members worldwide. AGC Biologics is a part of AGC Inc.'s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
an hour ago
- Business Wire
HistoSonics and Cambridge University Unveil Europe's First Edison™ Histotripsy System Powered by Li Ka Shing Foundation Gift
MINNEAPOLIS--(BUSINESS WIRE)-- HistoSonics, the manufacturer of the Edison® Histotripsy System and novel histotripsy therapy platforms, announced today that Addenbrookes Hospital of Cambridge University Hospital Foundation and Trust will be the first site in the United Kingdom and European continent to offer histotripsy to both NHS and private patients. This was made possible through a generous donation by the Li Ka Shing Foundation (LKSF) as well as the expedited limited market access granted by the MHRA in April 2025. 'We are grateful to the Li Ka Shing Foundation for their visionary support. With Addenbrookes as our first NHS hospital site under UCNA, we are laying the foundation for future expansion," said Mike Blue, President and CEO, HistoSonics. The milestone marks HistoSonics' official entry into the UK and European market. HistoSonics won a coveted place in the Innovative Device Access Pathway pilot in 2024 and through this program, in partnership with the DHSC, MHRA, NIHR, NHSE, and NICE expedited access to patients. HistoSonics will continue to work with UK healthcare stakeholders on our aligned goal of urgently expanding access for all NHS patients. The Li Ka Shing Foundation, established in 1980 by Hong Kong philanthropist Sir Ka-shing Li, has contributed nearly US$4 billion to advancing education, medical research and services, and poverty alleviation across the USA, UK, Canada, and Asia. Recognizing the transformative potential of technological innovation in healthcare, the Foundation's latest gift to the University of Cambridge will build upon its previous donations of five Edison systems with three to Hong Kong, one to Singapore, and one recently to Stanford University. This new gift not only heralds the introduction of the first Edison system in the UK and Europe but also celebrates the enduring partnership between the Li Ka Shing Foundation and Cambridge in their collaborative efforts to fight cancer. By supporting cutting-edge medical technologies that can deliver low cost and highly efficient solutions, the Foundation hopes to enhance patient access with improved healthcare around the world. 'This donation is an historic milestone that brings non-invasive treatment of liver tumors using histotripsy to the UK,' said Mike Blue, President and CEO, HistoSonics. 'We are grateful to the Li Ka Shing Foundation for their visionary support. With Addenbrookes as our first NHS hospital site under UCNA, we are laying the foundation for future expansion into innovation driven hospitals across the UK.' The Edison System, which received FDA De Novo clearance in October 2023, uses non-invasive therapeutic focused ultrasound energy to mechanically destroy and liquefy targeted tissue and tumors without the invasiveness or toxicity of traditional procedures, reducing the risks of bleeding, infection, and damage to surrounding non-targeted tissue. HistoSonics' initial FDA clearance is for the destruction of liver tumors, with ongoing studies focusing on kidney tumors (HOPE4KIDNEY Trial NCT05820087) and pancreas tumors (GANNON Trial NCT06282809). Professor Deborah Prentice, Vice-Chancellor of the University of Cambridge, said: 'We are very fortunate that through the generosity of Sir Ka-shing Li, Addenbrooke's Hospital in Cambridge will be able to use cutting-edge histotripsy technology to improve outcomes for NHS patients. It is technology such as this that allows Cambridge to remain at the forefront of understanding and treating tumors, a position we aim to strengthen further with Cambridge Cancer Research Hospital.' With installations soon to be in five countries including the US, UK, Hong Kong, Singapore and the United Arab Emirates, HistoSonics is actively expanding access to its histotripsy platform and is working closely with clinical leaders, national health systems, and philanthropic partners to accelerate global adoption of histotripsy as a new category of health care. HistoSonics is also pursuing broader UK and European market access via CE marking. United Kingdom Intended Use Statement: The Edison System is intended for the non-invasive mechanical destruction of liver tumours, including the partial or complete destruction of unresectable liver tumours via histotripsy. This includes malignancy linked to primary liver cancer and cases of metastatic disease in the liver. The device should only be used by people who have completed training performed by HistoSonics Inc., and its use guided by the clinical judgement of an appropriately trained physician. Users must read this user guide to understand the warnings, precautions, and clinical trial summary, including reported adverse events. The Edison System has not been evaluated for the treatment of any specific disease, including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumour progression, 5-year survival or overall survival). United States Intended Use Statement: The Edison System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by physicians who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions, and a summary of clinical trial results, including reported adverse events. About HistoSonics HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing the science of histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing their Edison System in the US and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, Michigan and Minneapolis, MN. For more information on the Edison Histotripsy System please visit: For patient-related information please visit:
Yahoo
4 hours ago
- Yahoo
WaterField's New All-Day Shinjuku Duffel Masters Work, Workout, and Weekends
San Francisco's WaterField Designs introduces the Shinjuku Duffel, featuring dedicated spaces for office gear, clothing, and quick-access essentials. The new carryall combines the professional aesthetic of a briefcase with expanded capacity for fitness and travel, allowing busy professionals to navigate their day with a single, sophisticated bag. SAN FRANCISCO, June 10, 2025 /PRNewswire/ -- San Francisco's WaterField Designs introduces the Shinjuku Duffel, the latest addition to the company's Shinjuku Collection, inspired by the dynamic energy of Tokyo's Shinjuku district. Crafted from ultra-lightweight, water-resistant X-Pac® Canvas or traditional waxed canvas with premium full-grain leather accents, the new compact duffel features three distinct compartments that elegantly organize the essentials of today's digital nomads – from protecting tech devices on daily commutes, to storing gear for lunchtime workouts, to organizing necessities for overnight trips. VIDEO: Tour the Shinjuku Duffel "Many professionals juggle multiple bags throughout their day – a briefcase for work, a gym bag for fitness, and yet another weekender bag for overnight trips," explained company owner Gary Waterfield. "Our Shinjuku Duffel is your ideal everyday, all-day holdall that blends professional aesthetics and flexible functionality for an efficient way to carry just one handsome bag throughout your day." The Shinjuku Duffel's intelligent design solves common carryall frustrations. The bag's layout, structure, and ample organization allow it to hold an overnight's worth of gear without being large and bulky—nothing is swimming around. Its size and quick-access pockets facilitate smooth commuting, so users aren't fishing for their wallet in a large black hole or swinging an unruly bag shaped like a battering ram in crowded spaces. The Shinjuku Duffel's three-zone organization system includes: a dedicated office compartment with padded laptop and tablet sleeves; a spacious main compartment for personal, fitness, or overnight necessities with organization pockets and a collapsible water bottle sleeve; and a full-length zippered front pocket for quick-access items with internal organization and a key tether. This thoughtful separation of work gear from clothing and smaller items caters to commuters, hybrid workers, and frequent travelers. A rear magnetic pocket securely holds passports and other valuables against the body. The main compartment features a full-length zipper that extends down the sides allowing the bag to open wide, while internal gussets keep contents in place. This feature enables users to easily pack, locate, and access items anywhere in the duffel bag, even those at the bottom. A gold, water-resistant liner brightens the interior eliminating the "black hole" effect common to standard duffels. The bright liner also resists stains and wipes clean easily. The Shinjuku Duffel is offered in X-Pac® Canvas – a high-performance textile that combines ultra-lightweight, water-resistant, and highly durable X-Pac® with canvas for a soft touch – making the bag feel light even when fully packed. The duffel is also available in rugged waxed canvas for those preferring a classic, well-traveled aesthetic. Both options feature sumptuous full-grain leather accents. Features: Three custom compartments: A dedicated office section with a padded laptop sleeve with charging cutouts (for up to a 16-inch MacBook Pro), a padded tablet pocket (for up to a 13-inch iPad Pro), and a full-length document pocket. A spacious main compartment with four elevated translucent mesh pockets and a retractable water bottle holder. A three-quarter zipper opens wide and internal gussets keep contents secure. A pleated full-length front quick-access pocket with internal mesh pockets, pen slots, and a key tether. A hidden, magnetic rear pocket holds passports, transit cards, and other quick-access items. Closed-cell foam padding on front, rear, and bottom panels add structure and enhance protection and durability. Gold, easy-clean liner illuminates interior for enhanced visibility. Three carry options ease transport: comfortable leather-wrapped handles, suitcase handle pass-through, and WaterField's removable Supreme Suspension Strap. Available in ultra-light, abrasion and water-resistant X-Pac® Canvas or traditional waxed canvas, each paired with full-grain leather accents, YKK waterproof zippers, and custom metal hardware combine for a look suitable in both formal and casual settings. Handcrafted to exacting standards in San Francisco with a lifetime warranty for defects in materials and workmanship for the product's lifetime. The Shinjuku Duffel is the sixth addition this year to WaterField's Shinjuku Collection of bags, inspired by Tokyo's vibrant trendy neighborhood, each designed to combine mobility and accessibility with sophisticated styling. The new duffel joins WaterField's collection of carryall bags for active professionals. Availability & Pricing: The Shinjuku DuffelPrice: $419Colors and materials: X-Pac® canvas in black or olive green with black full-grain leather accents; navy blue or tan waxed canvas with chocolate full-grain leather accents. Gold ripstop nylon YKK® waterproof zippers, custom metal zipper pulls, rare-earth and weight: 16.5 x 10.5 x 10.5 inches; X-Pac® Canvas 2.4 lbs.; Waxed Canvas 2.85 lbs.; 27 liters. Available now at About WaterField Designs WaterField Designs is an innovative San Francisco designer and manufacturer of bags and cases for tech-savvy consumers who want to stylishly and responsibly transport their technology. WaterField manufactures custom-fitted, high-quality cases and bags for a full range of laptop computers, smartphones, tablets, gaming devices, and other digital gear. All products are manufactured to exacting standards entirely in San Francisco. More information is available at the company website under "Our Story." WaterField Designs, Shinjuku Duffel, Shinjuku Collection, and SFBags are trademarks of WaterField Designs. Other company and product names may be trademarks of their respective owners. Copyright ©2025. All Rights Reserved. View original content to download multimedia: SOURCE WaterField Designs Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 hours ago
- Yahoo
Anteris Appoints David Roberts and Gregory Moss to its Board of Directors
New Directors Bring Extensive NASDAQ Expertise Across Legal, Operational and Corporate Leadership Capacities MINNEAPOLIS and BRISBANE, Australia, June 09, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced the appointments of Mr. David Roberts and Mr. Gregory Moss to its Board of Directors. The Company also announced the resignation of Dr. Wenyi Gu from the Board upon completion of his term as an Australia-based non-executive director. 'On behalf of the management team and Board, I am delighted to welcome David and Gregory to the Company' commented John Seaberg, Chairman of Anteris. 'On the heels of our Q4 2024 listing onto NASDAQ, and as we ramp-up activities to launch the DurAVR® THV global, pivotal clinical trial (the "PARADIGM Trial"), we are excited to enhance the leadership team with two highly accomplished, U.S. based, healthcare executives as the company transitions to its next phase of growth. I also wish to extend gratitude to Dr. Gu for his commitment and contributions to the company over the course of his tenure as a member of the Board and wish him well on his future endeavors.' Mr. David Roberts is currently President of LeMaitre Vascular, Inc. (NASDAQ: LMAT), a position he has held since 2007. He joined LeMaitre in 1997 as Vice President of Business Development and was promoted to Chief Financial Officer in 2000. Prior to LeMaitre, Mr. Roberts served as Vice President of Development for BUCA, Inc. from 1994 to 1997, and prior to that as Associate of HarbourVest Partners from 1992 to 1994. Mr. Roberts received a Bachelor of Arts in Business Economics and History from Brown University and a Master of Business Administration from the Stanford University Graduate School of Business. Mr. Roberts serves as a director of LeMaitre Vascular, Inc., Lexington Medical, Inc. and Parasole Restaurant Holdings, Inc. Mr. Gregory Moss serves as Chief Business and Legal Officer, as well as Corporate Secretary and Chief Compliance Officer of Evommune, Inc. Prior to Evommune, Mr. Moss served as Executive Vice President, General Counsel, and Corporate Secretary, Chief Compliance Officer at Kadmon, a Sanofi Company, where he led legal, compliance, and business development operations, culminating in Kadmon's $1.9 billion acquisition in 2021. Prior to joining Kadmon in 2012, Mr. Moss served as a solicitor in the corporate risk department of a large Australian law firm and as an associate at a boutique law firm and hedge fund in New York, where he focused on complex litigation and event-driven outcomes. Mr. Moss currently serves on the board of Vitls, Inc. Mr. Moss earned a BA and an LLB from Macquarie University, Australia, and is a member of the Bar Associations of New York, USA, and New South Wales, Australia, with admissions before the Supreme Court of the United States of America; Southern District of New York; Supreme Court of New South Wales, Australia; and High Court of Australia. Mr. Roberts and Mr. Moss will help guide Anteris through its next phase of growth, with the upcoming global pivotal PARADIGM study in 3Q2025 towards the ultimate U.S. and EMA licensure of the DurAVR® THV for patients with aortic stenosis. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris' lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world's leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris' patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. For more information: Investor Relations investor@ OrmsbyAnteris Technologies Global Corp.+61 1300 550 310 | +61 7 3152 3200 Investor Relations (US)mchatterjee@ Chatterjee, Life Science Group+1 917 330 4269WebsiteXFacebookLinkedIn in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
