Viralgen Vector Core SL

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. DHL Supply Chain has invested £550 million ($748 million) to expand its infrastructure in the UK and Ireland to support growing demand for healthcare and life science logistics, the company said Wednesday. Novo Nordisk is investing 800 million Chinese yuan ($112 million) to build a quality testing laboratory at its site in Tianjin, China, according to a Tuesday release in Chinese. The 18,000-square-meter lab is expected to be completed by the end of 2026. Bavarian Nordic has secured a DKK 200 million ($31.5 million) award to supply its smallpox and mpox vaccine, dubbed MVA-BN, to an unnamed European country. The order will be delivered in 2025, according to the Wednesday release. Almac Clinical Services has completed its “multi-million pound” expansion at its headquarters in Northern Ireland, the company said Monday. The expansion included a low-temperature facility with packaging service and storage capacity. The European Commission launched two initiatives on Wednesday to improve access to medicines. The first initiative, called the EU Stockpiling Strategy, will see member states coordinate drug stocks, identify shortages and improve logistics. The second initiative, called the Medical Countermeasures Strategy, will see the EU boost development of new antibiotics and other drugs and create a list of priority medical countermeasures, among others. Gerresheimer reported a 15.7% increase in revenue for the first half of 2025, reaching €1.1 billion ($1.3 billion), according to a Thursday release. The company expects more growth in the second half of the year due to a high number of orders and production ramp-ups. Alvotech has acquired Swiss packaging company Ivers-Lee, according to a Wednesday release. Ivers-Lee will remain as a separate company but its site in Burgdorf, Switzerland, will be integrated into Alvotech’s technical operations division. Myrtelle has launched commercial manufacturing for its oligotrophic recombinant adeno-associated virus gene therapy product, which is currently being investigated in a Phase 2 study for Canavan disease. Myrtell has tapped Charles River to make plasmids for the gene therapy at its site in Keele, UK, while Viralgen will make vectors in San Sebastián, Spain, according to a Tuesday release. Sartorius Stedim Biotech signed a Memorandum of Understanding with Slovakia-based Sensible Biotechnologies to scale up the latter’s mRNA manufacturing platform, according to a Wednesday release. The two companies will aim to produce clinical-stage mRNA by 2026, with the partnership expanding Sensible Biotechnologies’ production to the US, UK and Europe.

Team prepares for commercialization bolstered by START Program and regulatory recognition NEW YORK, NY, USA I July 8, 2025 I Myrtelle Inc. (“Myrtelle” or the “Company”), a pioneering clinical-stage gene therapy company dedicated to revolutionizing treatment for neurodegenerative diseases, today announced the official launch of commercial-stage manufacturing for its first-in-class oligotrophic recombinant adeno-associated virus (rAAV) gene therapy product, developed specifically for Canavan disease (CD). This landmark achievement propels Myrtelle’s therapy closer to market and patients who urgently need it. The manufacturing program is being executed in strategic partnership with two global leaders in gene therapy infrastructure: Charles River and Viralgen Vector Core (a subsidiary of AskBio Inc.) . Together, the trio is setting a new standard in viral vector innovation, combining Myrtelle’s proprietary science with Charles River’s GMP plasmid manufacturing and analytical excellence at their CDMO center of excellence in Keele, UK, and Viralgen’s cutting-edge GMP vector production at their world-class facility in San Sebastián, Spain. Myrtelle Launches Commercial-Stage Manufacturing for Gene Therapy Product Targeting Canavan Disease “This is a transformative moment for Myrtelle and the entire Canavan disease community,” said Adrian Stecyk, Chief Executive Officer of Myrtelle . “Initiating commercial manufacturing represents the culmination of our bold vision—to translate deep scientific innovation into real-world therapies. With Charles River and Viralgen as our partners, we are poised to deliver a life-changing treatment with precision, scalability, and speed.” At the heart of this initiative is MYR-101 , Myrtelle’s pioneering rAAV-Olig001-ASPA gene therapy. Engineered with a unique tropism for oligodendrocytes—the myelin-producing cells compromised in Canavan disease—MYR-101 is designed to directly address the genetic root of the disorder by restoring ASPA enzyme function and supporting normal brain development. This targeted approach has the potential not only to halt disease progression but to enable true neural repair through remyelination. “When every day, every hour, every minute makes a difference in saving lives, the Charles River team is excited and privileged to continue to support Myrtelle at this pivotal stage,” said Kerstin Dolph, Corporate Senior Vice President of Global Manufacturing at Charles River . “Myrtelle’s groundbreaking program exemplifies the progress gene therapy has made from concept toward commercial reality, and we’re proud to be part of that journey, bringing hope to the patients and families affected by Canavan disease.” “Our mission at Viralgen is to transform people’s lives through our manufacturing science,” said Jimmy Vanhove, Chief Executive Officer at Viralgen . “Myrtelle’s work in Canavan disease is extraordinary, and we are honored to contribute our expertise and advance GMP production to help make this therapy a reality.” Myrtelle’s gene therapy program continues to gain momentum on multiple fronts. The Company remains on track to finalize regulatory filings and prepare for commercial launch, pending approvals. MYR-101 was selected as one of just four programs to participate in the FDA’s Support for Clinical Trials Advancing Rare Disease Therapeutics (START) Pilot Program , a groundbreaking initiative to accelerate development of treatments for serious rare diseases by enhancing regulatory communication and flexibility. The company’s progress has also been recognized globally with multiple key designations awarded to rAAV-Olig001-ASPA, including: With manufacturing now underway in preparation for commercialization, Myrtelle is accelerating toward its goal of delivering the first approved therapy for Canavan disease , opening a new chapter in the treatment of rare neurodegenerative conditions—and offering a profound message of hope to patients and families around the world. About Myrtelle Myrtelle Inc. is a gene therapy company focused on developing transformative treatments for neurodegenerative diseases. The Company has a proprietary platform, intellectual property, and portfolio of programs and technologies supporting innovative gene therapy approaches for neurodegenerative diseases. Myrtelle has an exclusive worldwide licensing agreement with Pfizer Inc. for its Canavan disease program. For more information, please visit the Company’s website at: www.myrtellegtx.com . About Canavan Disease Canavan disease (CD) is a fatal childhood genetic brain disease caused by mutations in the ASPA gene (ASPA) which prevent the normal expression of aspartoacylase, a critical enzyme produced in oligodendrocytes. The lack of normal aspartoacylase expression negatively impacts brain bioenergetics and development, including myelin production. Patients with CD are impacted at birth but may appear normal until several months old when symptoms begin to develop. Poor head control, abnormally large head size, difficulty in eye tracking, excessive irritability, severely diminished muscle tone, and delays in reaching motor milestones, such as rolling, sitting, and walking, are the typical initial manifestations of CD. As the disease progresses, seizures, spasticity, difficulties in swallowing, and overall muscle deterioration emerge with most affected children developing life-threatening complications by approximately 10 years of age. Currently, there are no cures for CD, and only palliative treatments are available. More information on Myrtelle’s clinical trial in Canavan disease can be found on https://clinicaltrials.gov/ under the identifier NCT04833907 or by emailing PatientAdvocacy@MyrtelleGTX.com . SOURCE: Myrtelle

Glioblastoma is an aggressive brain cancer form. Credit: Komsan Loonprom/Shutterstock. Contract development and manufacturing organisation (CDMO) Viralgen has partnered biotech company Trogenix to accelerate the development of a recombinant adeno-associated virus (rAAV) gene therapy for glioblastoma, an aggressive brain cancer. The partnership has enabled Viralgen to scale up and complete a good manufacturing practice (GMP) trial material batch of Trogenix’s TGX-007 in under twelve months, expediting it to the first-in-human (FIH) glioblastoma trial. Viralgen has focused on manufacturing and also on the development of a gene-specific titration method and a custom-specific formulation buffer to act as a diluent for the administration of the drug product – crucial in progressing Trogenix’s gene therapy. Trogenix CEO Ken Macnamara stated: “At Trogenix, our aim is to transform cancer treatment from chronic disease management to a potentially curative one-time treatment. “By collaborating with Viralgen, we can rapidly scale product supply and bring the therapy to patients as quickly as possible.” Odysseus, the synthetic super-enhancers platform of Trogenix, is designed to develop precision genetic medicines targeting disease cell states. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence With the first GMP batch of Trogenix’s rAAV vector manufactured at Viralgen’s facility, the gene therapy is now set to move into clinical assessment. Viralgen CEO Jimmy Vanhove stated: “Our expertise in rAAV vector manufacturing and ability to scale allows us to support and accelerate critical clinical therapeutic programmes. “We are thrilled to contribute to Trogenix’s pioneering approach in oncology gene therapy, which has potential for curative responses in glioblastoma and other cancers.” Founded in 2017 as a subsidiary of AskBio within the Bayer group, Viralgen is focused to expediting the AAV-based therapy development. The company leverages the Pro10 suspension manufacturing platform, which can achieve high titers [strength or concentration of a substance, often antibodies, in a solution] across all AAV serotypes. Viralgen also provides services to assist in the transition from clinical to commercial manufacturing. In January 2025, Viralgen announced that it was set to form a partnership with Axovia Therapeutics to progress the development and manufacturing of an AAV9-based gene therapy for retinal dystrophy in individuals with Bardet-Biedl syndrome due to BBS1 gene mutations. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic You have a right to withdraw your consent at any time, by clicking here . We may still continue to send you service-related and other non-promotional communications. For more information relating to our privacy practices, we invite you to review our privacy policy .