Charles River Laboratories, Inc.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Exothera has shut down due to the “increasingly challenging” CDMO landscape, the company said in a post last Wednesday on LinkedIn. Exothera specialized in manufacturing viral vectors and nucleic acids. It had multiple contracts, including manufacturing an intranasal vaccine against SARS-CoV-2 for the National Institutes of Health. It also previously secured a contract with Vaxthera in January to make its Phase 1 Covid-19 vaccine. Other recent customers include Sun Biotech, Asgard Therapeutics and Meissa Vaccines. Lotte Biologics has secured a late-stage commercial contract with an undisclosed US pharma company, it said Tuesday. Lotte will manufacture a Phase 3 asset and will extend into commercial production if the asset is approved. The contract will expire in 2030. Thermo Fisher Scientific has completed its acquisition of Sanofi’s facility in Ridgefield, NJ, according to a Tuesday release. The site now falls under Thermo Fisher’s pharma services business and will continue making certain products for Sanofi. The deal was originally announced in July. Charles River Laboratories has partnered with Akadeum Life Sciences to incorporate Akadeum’s cell separation technology, dubbed the Human T Cell Leukopak Isolation Kit-GMP, into its cell therapy program, according to a Wednesday release. Clinical-stage BioFactura announced on Wednesday it has launched a new CDMO division for early clinical-stage manufacturing. The unit, named Capitol Biologics, will be located in DC, and will provide services covering monoclonal antibodies, recombinant proteins and other biologics. Denis Johnson started his new role as CEO for Grand River Aseptic Manufacturing on Monday. Johnson has acted as president of the company since March this year. He will replace Derek Hennecke, who will join the board of directors after serving as CEO since September 2024. Amneal Pharmaceuticals was handed an FDA warning letter on Aug. 27 after an inspection of its facility in Gujarat, India, between March 10 and March 19. The letter outlined three major issues, which included lack of proper investigations into recurring problems of visible particulate matter found in polypropylene bags, which can lead to “significant health risks” in patients. Aspen Pharmacare is working to commercialize an insulin product with an unnamed customer to grow the manufacturer’s revenue by 2027. This comes after the South Africa-based company said on Wednesday that its manufacturing business pulled in 21% lower revenue for the year ending in June. Further, due to an mRNA production contract dispute with another customer, Aspen’s manufacturing EBITDA declined by 62%. Scinai Immunotherapeutics’ CDMO business pulled in around $421,000 for the first half of 2025, according to a Tuesday release. Its manufacturing unit helped boost its overall revenue, which reached $773,000 for the first half of 2025, compared to the $284,000 reported in the same period last year. Medical device manufacturer Quasar Medical has completed its acquisition of Nordson Medical’s contract manufacturing business, which operates out of a facility in Galway, Ireland, and another in Tecate, Mexico. Quasar plans on expanding its team by 200 more staffers, the Tuesday release states. Eurofins Viracor BioPharma Services is relocating its headquarters to a new 96,000-square-foot facility in Lenexa, KS, according to an Aug. 29 release. The move will be completed in September. Eurofins Viracor BioPharma Services was spun out in 2020 and was previously co-located with its parent company Eurofins Viracor. Minebea Intec is expanding its facility in Hamburg, Germany, through a “seven-figure” investment, the company said Tuesday. The expansion will increase capacity for load cell production. Ori Biotech has secured an Advanced Manufacturing Technology designation from the FDA for its cell and gene therapy manufacturing platform, the company said Wednesday. CDMO Naobios, biotech Nuvonis and the European Vaccine Initiative are partnering to develop an influenza A Human Viral Challenge Agent, according to a Tuesday release. The collaboration falls under the Inno4Vac consortium, which aims to improve vaccine production. The Zambia National Public Health Institute signed a Memorandum of Understanding with the International Vaccine Institute to improve Zambia’s local vaccine manufacturing, according to a Thursday release. EnsiliTech has raised £4.5 million ($6 million) in an oversubscribed seed funding, which will be used to boost the company’s infrastructure and hire more staff, according to an Aug. 28 release. EnsiliTech focuses on storage and transport of drugs. Indian CDMO Piramal Pharma Solutions will manufacture George Medicines’ hypertension drug, with the brand name Widaplik, as a part of a new partnership, the company said on Aug. 28. Widaplik was approved by the FDA on June 6. CDMO Cytovance Biologics is expanding its services to include formulation development capabilities, the company said Wednesday.

Fresenius Kabi and Charles River are among 18 partners in a new EU-backed consortium that aims to develop an automated, hospital-based manufacturing platform for CAR-T therapies. Fresenius and Charles River Laboratories are among 18 academic, research, industry and clinical partners that have formed a new European Union-supported consortium to develop an automated, hospital-based manufacturing platform for CAR-T cell therapies.The consortium, dubbed EASYGEN (Easy Workflow Integration for Gene Therapy), is backed by €8 million ($9.3 million) in funding from the EU’s Innovative Health Initiative, Fresenius Kabi—the German drugmaker leading the effort—said in an Aug. 26 press release.The EASYGEN consortium will set out to develop an automated, hospital-based production platform that can crank out CAR-T therapies in less than 24 hours and at a lower cost than current manufacturing approaches allow, according to multiple press releases from the group's members this week.CAR-T therapies, which genetically engineer a patient’s T cells to identify and attack cancer cells, have faced numerous challenges since the 2017 debut of the class with Novartis' Kymriah, including significant manufacturing and scalability hurdles.“The current manufacturing process for CAR-T therapies is time-intensive and severely limits their clinical application,” Julia Schueler, Ph.D., head of Charles River’s oncology unit, said in a statement. “By collaborating across industry and academia, I am hopeful we can design a streamlined workflow that will increase access to these therapies for patients who need them.”The consortium’s proposed bedside manufacturing platform will leverage technology originally developed by the cell and gene therapy unit of Fresenius' Fresenius Kabi, as well as Charles River’s 3D screening technologies and Cellix’s Inish Analyser, which measures cell viability and cell numbers to monitor safety and quality.  “The aim is not only to develop cutting-edge medical technologies, but also to make them available quickly, safely, and close to the patient,” Christian Hauer, Ph.D., Fresenius Kabi's medtech president, said in a statement. “In this way, we are actively working to shape the healthcare of tomorrow.”In Europe, access to CAR-T therapies is currently limited despite many patients qualifying for the treatments, the group said. Citing a report from IQVIA, Fresenius noted that the average treatment rate spanning five countries in the region is currently below 20%. That number is slightly higher at 30% in France, while it drops to just 11% in Italy.“Automation can help reduce production complexity of these therapies, with the aim of making it easier to scale these life-saving treatments and improve patient access,” said Ralf Kuhlen, chief medical officer at Fresenius.Aside from Fresenius and Charles River, other members of the EASYGEN consortium include: Helios Hospital Berlin-Buch, Quirónsalud, Fenwal, Pro-Liance Global Solutions, TQ Therapeutics and Philips Electronics.The group also includes a number of academic and research institutions, such as Fraunhofer IESE; Fraunhofer IZI; Helmholtz-Zentrum Dresden-Rossendorf; Technical University of Denmark; Frankfurt School of Finance & Management; European Society for Blood & Marrow Transplantation; Bar-Ilan University; University of Glasgow; and the University of Navarra.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Johnson & Johnson was handed a complete response letter for a potential label expansion of Darzalex Faspro over issues found after a facility inspection, the company said Friday. Darzalex Faspro is being reviewed in a quadruplet regimen in newly diagnosed, transplant-ineligible multiple myeloma. No safety or efficacy concerns were raised and no new clinical data are needed. Charles River Laboratories said during its second-quarter earnings call Wednesday that overall demand from its pharma clients appears to be stabilizing, but smaller biotechs are still constrained over a lack of funding. The company is not yet seeing any “meaningful impact on client spending patterns” due to tariffs or drug pricing issues, CEO James Foster said. Charles River has been slightly affected by NIH funding cuts, but this only a “small impact,” Foster added. Overall, the company reported a revenue of $1.03 billion for Q2, up 0.6% from the $1.02 billion reported in the same period last year. CDMO Esteve is acquiring Chicago-headquartered CDMO Regis Technologies, in a move that would see it expand to the US for the first time, the company said July 31. This deal expands Esteve’s services to include manufacturing of small molecule APIs for preclinical to commercial purposes. Indian API maker Garonit Pharmaceutical is building a $46.1 million facility in New Windsor, Orange County, according to a Monday release. The 200,00-square-meter site will manufacture antiseptic products. New York State is investing $3.8 million to aid the project. Bora Pharmaceuticals is expanding its facility in Maple Grove, MN, the company said Tuesday. The first step of the expansion is to be operational in Q3. Fresenius Kabi and Polpharma Biologics have entered into a new licensing agreement, according to a Tuesday release. Fresenius Kabi will exclusively commercialize Polpharma’s biosimilar to the biologic vedolizumab, sold by Takeda under the brand name Entyvio, which is used to treat Crohn’s disease and ulcerative colitis. API maker Axplora is investing €6.5 million to expand a site in India, the company said Tuesday.