CD276

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Evonik is discontinuing keto acid manufacturing at its site in Hanau, Germany, by the end of 2025 and will lay off around 260 workers. The company is also looking at divestment and partnership options for its keto and pharma amino acid facilities in France and China, according to an Oct. 11 release. Italian biopharma Chiesi is launching a new €400 million ($433 million) facility in Europe to make monoclonal antibodies, enzymes and other proteins, the company said Monday. The new site will employ 200 staffers by the end of 2025. Indiana-headquartered SpectronRx is expanding to Europe with the radiopharma CDMO earmarking $50 million to build a radiolabeling facility for actinium-225 assets, the company told Endpoints Thursday. Construction in Mol, Belgium, is anticipated to be completed next month, with the site to be operational by the first quarter of 2025. EuroAPI has appointed Olivier Falut as its new chief financial officer. He is replacing Evelyne Nguyen who will stay at the company until the end of October, according to a Wednesday release. The company is in its “year of transition” as it undergoes major restructuring. Texas-based CDMO Matica Biotechnology has signed a new contract with biotech Mongoose Bio, the companies announced Wednesday . Matica Bio will manufacture lentiviruses for Mongoose Bio’s T cell receptor-engineered T cell therapy for cancer. RadioPharma CDMO AtomVie has partnered with Radiopharm Ventures, the company said Tuesday. AtomVie will manufacture the clinical-stage 177 lutetium-conjugated B7-H3-targeting radio antibody, dubbed 177Lu-BetaBart. Perspective Therapeutics’ manufacturing facility in Somerset, NJ, is now operational and has sent its first shipment, the company said Wednesday. The facility manufactures lead-203 and lead-212-labeled radiopharmaceuticals. Cellular Origins and Fresenius Kabi have embarked on a new collaboration for cell therapy manufacturing, the companies announced Wednesday. Cellular Origins will integrate Fresenius Kabi’s cell therapy processing tech into its robotic manufacturing platform, with the aim to manufacture cell therapies on a larger scale. CDMO Cambrex’s storage subsidiary Q1 Scientific has opened a new facility in Durham, NC, to expand storage capacity for pharmaceutical, medical device and life science customers in North America, Cambrex said Wednesday.

The collaboration intends to strengthen both companies’ expertise to develop new radiotherapeutic solutions for cancer. Credit: Frame Stock Footage/Shutterstock. Radiopharm Theranostics (RAD) and AtomVie Global Radiopharma have announced a partnership for the development and manufacturing of 177 Lu-BetaBart radioantibody to treat multiple solid tumours. The partnership has been formed with Radiopharm Ventures (RV), a joint venture between RAD and the MD Anderson Cancer Center (MDACC). 177 Lu-BetaBart is a 177 Lutetium-conjugated radioantibody that targets the immune checkpoint molecule B7-H3, which is heavily exhibited in various tumour types and associated with aggressive cancer and poor patient outcomes. The collaboration intends to strengthen both companies’ expertise to producenew radiotherapeutic solutions for cancer, addressing significant unmet medical needs. The first targeted radiopharmaceutical against the 4Ig subtype of B7-H3, 177 Lu-BetaBart was engineered at MDACC to have a lesser blood circulation time and decreased on-target off-tissue toxicity. See Also: Health Canada approves Acadia’s DAYBUE for Rett syndrome COPD market expected to grow to $30.8bn in the 7MM by 2033 RAD managing director and CEO Riccardo Canevari stated: “Our collaboration with AtomVie is a significant step forward in our mission to bring innovative radiopharmaceutical therapies to patients. “Their proven track record in manufacturing and global distribution assures us that we are in capable hands as we progress through the clinical stages and prepare for potential commercialisation.” The partnership unites RAD’s portfolio of radiotherapeutic products with AtomVie’s capabilities in manufacturing and global distribution of radiopharmaceuticals. The 177 Lu-BetaBart project is part of a broader pipeline of unique technologies developed by RAD and RV, including small molecules, peptides and monoclonal antibodies, all sourced from universities and institutes worldwide. AtomVie CEO Bruno Paquin stated: “We are thrilled to partner with RAD on such an important project. With our expertise in radiopharmaceutical manufacturing, we are confident that we can support RAD in advancing its innovative pipeline. “This partnership reinforces our commitment to transforming patients’ lives with high-quality radiopharmaceuticals, as we continue to expand our capabilities in our new facility and empower novel radiotherapeutics to market.” A Phase I/II first-in-human trial of 177 Lu-BetaBart across multiple tumour types in the US is anticipated to commence by mid-2025.

HAMILTON, ON, Oct.15, 2024 /PRNewswire/ -- AtomVie Global Radiopharma (AtomVie), a leading radiopharmaceutical Contract Development and Manufacturing Organization (CDMO), has entered into an agreement with Radiopharm Ventures (RV), a Joint Venture between Radiopharm Theranostics (RAD) and MD Anderson Cancer Center (MDACC), to develop and manufacture 177Lu-BetaBart, a 177Lutetium-conjugated B7-H3 targeting radioantibody. This partnership leverages both companies' expertise to advance novel radiotherapeutic solutions in areas of high unmet medical needs. Continue Reading AtomVie Global Radiopharma and Radiopharm Theranostics Partner to Develop and Manufacture 177Lu-BetaBart Radioantibody for Treatment of Multiple Solid Tumors B7-H3 is an immune checkpoint molecule that is overexpressed in several tumor types and represents a highly attractive target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is linked with tumor aggressiveness and poor outcomes. 177Lu-BetaBart is the first targeted radiopharmaceutical in development against the 4Ig subtype of B7-H3, which is the most common subtype expressed on human tumors. The monoclonal antibody, invented at MDACC, has been specifically engineered with a shorter blood circulation time and reduced affinity for on-target off-tissue toxicity, leading to a final molecule that is highly promising for human use in clinical settings. Phase I/II First-In-Human therapeutic trial with 177Lu-BetaBart in multiple tumor types in the US, is expected for mid-2025 This collaboration brings together RAD's world-class platform of radiotherapeutic products and AtomVie's leading in manufacturing and distributing radiopharmaceuticals globally. 177Lu-BetaBart is part of a broader pipeline of distinct, highly differentiated technologies developed by RAD and RV. These span peptides, small molecules, and monoclonal antibodies for use in cancer, sourced from top-tier universities and institutes globally. The pipeline is designed with the strong potential to be either first-to-market or best-in-class. AtomVie's extensive expertise in clinical development, including technology transfer, process and method development, clinical supply and global distribution, provides a reliable foundation for advancing 177Lu-BetaBart from the clinic towards commercialization. With its new state-of-the-art, scalable 72,300 sq ft facility, set to open in early 2025, AtomVie is the partner of choice to support the growing global pipeline of radiotherapeutics. "Our collaboration with AtomVie is a significant step forward in our mission to bring innovative radiopharmaceutical therapies to patients," said Riccardo Canevari, Managing Director & CEO of RAD. "Their proven track record in manufacturing and global distribution assures us that we are in capable hands as we progress through the clinical stages and prepare for potential commercialization." Bruno Paquin, CEO of AtomVie, commented, "We are thrilled to partner with RAD on such an important project. With our expertise in radiopharmaceutical manufacturing, we are confident that we can support RAD in advancing their innovative pipeline. This partnership reinforces our commitment to transforming patients' lives with high-quality radiopharmaceuticals, as we continue to expand our capabilities in our new facility and empower novel radiotherapeutics to market." About AtomVie Global Radiopharma Inc. (AtomVie) AtomVie is a global leading CDMO for the GMP manufacturing and worldwide distribution of clinical and commercial radiopharmaceuticals. AtomVie offers the full range of scientific, technical, regulatory, quality, logistics, and business expertise combined with a specialized infrastructure for the development of radiopharmaceuticals from clinical studies to the commercial marketplace. AtomVie currently serves international clients conducting studies in over 25 countries worldwide. For more information, visit About Radiopharm Theranostics (RAD) and Radiopharm Ventures (RV) RAD is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need. RAD has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules, and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world's leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. RV is a Joint Venture between RAD and MDACC. Radiopharm Ventures brings together MDACC's proprietary technologies in antigen discover and molecular imaging, with RAD's expertise in developing radiopharmaceuticals. Learn more at [email protected] Photo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED