Latest news with #WuXiBiologics'
Cision Canada
a day ago
- Business
- Cision Canada
WuXi Biologics Launches HEK 293 Stable Cell Line Platform WuXia293 Stable for Development and Manufacturing of Difficult-to-Express Molecules
WuXia293 Stable platform demonstrates high titer, human glycosylation and improved product quality by eliminating or significantly alleviating truncation in difficult-to-express molecules. WuXia293 Stable platform maintains stable expression and consistent product quality during long-term cell passages, enabling scalable clinical and commercial manufacturing. SHANGHAI, Aug. 11, 2025 /CNW/ -- WuXi Biologics ( a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the launch of WuXia293 Stable, a new platform designed for the development and manufacturing of innovative, difficult-to-express molecules that are stably expressed in HEK293 cells. The platform, which demonstrates high titers, robust stability and superior quality, significantly enhances the developability and manufacturability of these molecules, offering a highly efficient CMC solution for biologics that are sophisticated in both structure and function. Conventionally, CHO cells have been widely utilized for recombinant protein expression with proven track record of high titers, and good developability and manufacturability. However, complex modalities may not be compatible with CHO expression system, resulting in low titer levels and truncation issues, due to the impact of some CHO-specific host cell proteins (HCPs), that compromise the quality and functionality of the protein products. In contrast, HEK293 cells can eliminate or significantly alleviate truncation issues in expressing complex molecules while maintaining high titer levels. WuXi Biologics developed WuXia293 Stable by leveraging its proprietary HEK293 cell line. Derived from WuXi Biologics' highly-vetted mammalian cell line development platform family WuXia™, WuXia293 Stable demonstrates productivity, quality and stability comparable to WuXia™ while maintaining full compatibility with its process, as shown by its robust growth and balanced metabolism. The platform achieves a fed-batch titer of up to 5.0 g/L for monoclonal antibodies while significantly improving purity. WuXia293 Stable offers flexible scalability in culture scale to meet the diverse needs of various research and pre-clinical development stages. Furthermore, the WuXia293 Stable cell line maintains stable expression and consistent quality during long-term cell passages, enabling scalable clinical and commercial manufacturing at 2000L scale for fed-batch and 1000L scale for perfusion. Moreover, WuXi Biologics offers a comprehensive suite of services for the WuXia293 Stable platform, including cell bank testing and viral clearance validation as part of its one-stop CMC solution. The launch of the WuXia293 Stable platform has further strengthened the service capabilities of WuXi Biologics' WuXia™ platform family. Besides WuXia293 stable, the WuXia™ platform has already derived multiple cell line development platforms, including WuXia ADCC Plus™ and WuXia RidGS™, to address customers' diverse requirements. Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are excited to launch an industry-leading solution that significantly enhances the development of advanced therapeutics. WuXia293 Stable stands as a powerful testament to WuXi Biologics' unwavering commitment to our vision that every biologic can be made and exemplifies our dedication to technological innovation, which enables us to adeptly address the evolving needs of the biopharmaceutical industry. Once again we are reaffirming our promise to enable our clients in accelerating the delivery of innovative biologics to patients worldwide. " About the WuXia™ Cell Line Development Platform Family WuXia™ is a proven, high-yield (up to about 11 g/L) mammalian cell line platform family developed by WuXi Biologics. Accepted by regulatory agencies worldwide, the WuXia™ platform family have generated over 1000 cell lines expressing monoclonal and bispecific antibodies, fusion proteins, enzymes and other recombinant proteins for clinical and commercial manufacturing as of 2024. The WuXia™ platform family include WuXia ADCC Plus™ for developing and manufacturing afucosylated antibodies to elicit an enhanced ADCC response, WuXia RidGS™ for non-antibiotic cell line development, and the latest WuXia293 Stable for expressing difficult-to-express molecules built on HEK293 cell lines. The WuXia™ cell line development platform family continue to expand to cater to the diverse needs of global customers.
Associated Press
09-06-2025
- Business
- Associated Press
WuXi Biologics Kicks off Construction of Microbial Manufacturing Site for Commercial Production in Chengdu
CHENGDU, China, June 9, 2025 /PRNewswire/ -- WuXi Biologics ( a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that it has kicked off construction of its new microbial manufacturing site for commercial production in the Wenjiang district of Chengdu, a renowned, vibrant hub for pharmaceutical development. Spanning an area of 95,000 square meters, the new site is dedicated to a drug substance (DS) facility and a drug product (DP) facility for commercial manufacturing, encompassing a wide array of modalities, such as peptides,antibody fragments, plasmid DNA, enzymes, cytokines, and virus-like particles (VLPs). Scheduled to complete GMP release for production by the end of 2026, the site will be equipped with a 15,000L fermenter, enabling an annual production capacity of 80 to 110 DS batches. In the long run, capacity will be able to expand to 60,000L. Notably, the facility will house China's first dual-chamber lyophilization production line alongside a vial filling line, with overall DP manufacturing capacity exceeding 10 million vials annually, a significant enhancement of WuXi Biologics' commercial manufacturing capabilities for the global market. The state-of-the-art facilities will feature WuXi Biologics' recently launched microbial expression platform EffiXTM for the development and manufacturing of biologics with high yield, consistent quality, and superior stability and scalability, achieving titers that exceed 15 g/L for non-mAb recombinant proteins. Equipped with advanced automated systems to help ensure regulatory compliance, operational efficiency, and uncompromising quality, the facilities have also been designed with a strong focus on energy conservation and sustainability. Through the optimization of process development approaches and implementation of comprehensive carbon tracking mechanisms, the company aims to minimize its environmental footprint while maintaining high production standards. WuXi Biologics will utilize the manufacturing site in Chengdu to produce VISEN Pharmaceuticals' inaugural commercial product, Lonapegsomatropin, a long-acting growth hormone for the treatment of pediatric growth hormone deficiency (PGHD). In addition to this landmark partnership, the company has also established strategic partnership with industry-leading biotech firm Virogen Biotechnology. These collaborations — centered around commercial manufacturing operations — underscore WuXi Biologics' expanding portfolio of partnerships and its drive to meet the growing demand for advanced biologic therapies. Dr. Chris Chen, CEO of WuXi Biologics, commented, 'We are excited to kick off the construction of Chengdu microbial manufacturing site, a powerful enhancement to add to our comprehensive end-to-end microbial solutions. With the booming global market for microbial products presenting unprecedented potential for next-generation therapies, our Chengdu site — with its robust production scale and cutting-edge technologies — is ideally positioned to capitalize on this trend. The strategic partnerships with leading pharmaceutical companies not only validate the capabilities of our new site but also represent a pivotal milestone in our unwavering commitment to accelerating the development and delivery of innovative therapies to patients worldwide.' View original content: SOURCE WuXi Biologics
Yahoo
17-05-2025
- Business
- Yahoo
WuXi Biologics Congratulates Partner CANbridge Pharmaceuticals on the Approval of Innovative Velaglucerase-beta for Injection (Gaurunning) for Gaucher Disease by China NMPA
Enabled by WuXi Biologics' industry-leading integrated technology platform, velaglucerase-beta for injection has successfully advanced from concept to commercialization. Velaglucerase-beta for injection, as the first and the only locally developed enzyme replacement therapy (ERT) for Gaucher disease in China, marks a significant breakthrough for CANbridge Pharmaceuticals and WuXi Biologics in advancing R&D of innovative rare disease therapeutics in China. Velaglucerase-beta for injection is the first innovative biological product in China to pass segmented manufacturing inspection. WUXI, China and SHANGHAI, May 16, 2025 /PRNewswire/ -- WuXi Biologics ( a leading global Contract Research, Development and Manufacturing Organization (CRDMO), congratulates its partner CANbridge Pharmaceuticals on the approval of its innovative velaglucerase-beta for injection (Gaurunning) by the China National Medical Products Administration (NMPA) for the treatment of adolescents aged 12 and above and adults with type I and type III Gaucher disease. This marks China's first and only locally developed enzyme replacement therapy (ERT) for Gaucher disease. Gaucher disease is a rare inherited genetic lysosomal storage disorder characterized by clinical manifestations such as hepatosplenomegaly, anemia, bone pain, and neurological symptoms, which can be life-threatening in severe cases. Recombinant human glucocerebrosidase ERT has been the standard treatment for Gaucher disease for 30 years, significantly improving major non-neurological signs and symptoms, as well as improving the quality of life for patients. It is estimated that the global prevalence of Gaucher disease is 0.7 to 1.75 per 100,000 people. Gaucher disease has been included in China's "First List of Rare Diseases". Velaglucerase-beta for injection is the first collaboration project on rare diseases between CANbridge and WuXi Biologics, advancing from concept to commercialization by leveraging WuXi Biologics' leading integrated technology platform. The project utilized innovative technology to construct high-expression cell line and achieved significant improvements in both yield and quality through WuXiUPTM, an ultra-high productivity continuous bioprocessing platform of WuXi Biologics. The overall yield increased by more than 110 times, and the specific enzyme activity increased by more than 50%, ensuring the affordability for Gaucher disease patients. Additionally, WuXi Biologics developed cell-based bioassay methods for commercial product release and stability testing, addressing the technical challenges of enzyme testing and effectively ensuring product quality control. Additionally, velaglucerase-beta for injection is the first innovative biological product in China to pass segmented manufacturing inspection. Dr. Chris Chen, CEO of WuXi Biologics, stated, "We are honored to enable CANbridge to achieve the significant milestone of approval for velaglucerase-beta for injection, which represents a critical advancement in rare disease drug innovation in China. Developing therapies for rare diseases is a long and challenging journey, requiring relentless joint efforts to bridge the gap between early-stage discovery and patients' access to medication. The successful commercialization of velaglucerase-beta for injection not only reflects CANbridge's decade-long dedication to rare diseases but also exemplifies the value of WuXi Biologics' integrated platform and CRDMO business model. Furthermore, our shared commitment to addressing the unmet clinical needs of rare disease patients has resulted in China's first locally developed ERT for Gaucher disease. We look forward to enabling more global partners to accelerate the development of high-quality rare disease therapies, and making them accessible and affordable for more patients suffering from rare diseases." Dr. James Xue, Founder, Chairman, and CEO of CANbridge Pharmaceuticals, stated, "Enzyme replacement therapy is a crucial part of CANbridge' global pipeline. The approval of velaglucerase-beta for injection in China is a milestone. By leveraging the integrated technology platform, velaglucerase-beta for injection will significantly reduce development costs, making safe and effective domestically produced ERT accessible and affordable for patients. This product is also the first collaboration project between CANbridge and WuXi Biologics in rare diseases. We extend our gratitude to our partners, including WuXi Biologics, who have empowered the development and manufacturing of velaglucerase-beta for injection. This milestone is not only CANbridge' third rare disease drug to be launched following Hunterase® and Livmarli®, but also the first in-house developed commercialized product. In the future, we will continue to focus on the localized research, manufacturing, commercialization, and accessibility of rare disease drugs, bringing innovative treatments to patients in China." Since its establishment, WuXi Biologics has been committed to enabling global innovative biotech companies to accelerate the rare disease drugs from concept to commercialization, benefiting rare disease patients worldwide. As ofthe end of 2024, there are 21 rare disease projects on the company's platform. Additionally, the company actively promotes public awareness and supports the rare disease patient community through various philanthropic initiatives. Its global "Run for Health" campaign has engaged over 2,500 participants to raise awareness for rare diseases. In China, the company's "Rare Disease Student Education Support Program" has provided scholarships to over 100 students affected by rare diseases over the past four years, fostering their academic growth. About Velaglucerase-beta for Injection (Gaurunning) Velaglucerase-beta for injection is the first domestically developed recombinant human glucocerebrosidase ERT in China, now approved for clinical use in treatment of Type I and Type III Gaucher disease patients. Most Gaucher disease patients are Type I and Type III, which are chronic non-neuronopathic and chronic neuronopathic forms, respectively. velaglucerase-beta is administered as an intravenous infusion and is intended to supplement the lack of glucocerebrosidase in the lysosomes of GD patients. The pivotal clinical trial of velaglucerase-beta achieved positive top-line data in August 2024. The velaglucerase-beta pivotal trial is a randomized, double-blind, dose-comparison study designed to evaluate the efficacy, safety, and pharmacokinetics of intravenous velaglucerase-beta administered every other week in newly treated Gaucher Disease (GD) patients, with an extension period. The results demonstrate that the study successfully met its primary efficacy endpoint, showing a statistically significant mean percentage reduction from baseline in spleen volume at nine months for both the 60 U/kg dose (P<0.0001) and the lower 30 U/kg dose (P<0.001). The primary endpoint of this trial protocol has been agreed upon by the CDE. About Gaucher Disease (GD) Gaucher disease, one of the most common lysosomal storage disorders, is a rare inherited genetic metabolic disease caused by autosomal recessive mutations in the GBA gene located on chromosome 1q22 and affects both males and females equally. Gaucher disease is a clinical spectrum that comprises Type 0 (perinatal-lethal), Type I (chronic non-neuronopathic), Type II (acute neuronopathic), and Type III (chronic neuronopathic) forms, with Types I and III surviving into adulthood. Gaucher disease is caused by a deficiency of glucocerebrosidase (acid b-glucosidase), an enzyme that helps break down a cellular membrane glycosphingolipid called glucocerebroside (glucosylceramide) inside lysosomes. As a result, glucocerebroside accumulates primarily in cells of the monocyte-macrophage lineage (Gaucher cells) within certain organs, leading to splenomegaly, hepatomegaly, anemia, thrombocytopenia, bone pain and fractures, and in the most severe forms (perinatal-lethal, Types II and III), early neurological symptoms. For 30 years, recombinant human glucocerebrosidase enzyme replacement therapy (ERT) has been the standard of care for Gaucher disease, with clinical trials and real-world data demonstrating significant improvement in the major non-neurological signs and symptoms of disease and quality of life. There were 3,000 patients with Gaucher disease in China in 2020, according to Frost & Sullivan. Gaucher disease has been included in China's "First List of Rare Diseases." About WuXi Biologics WuXi Biologics (stock code: is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide. With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects). WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain. For more information about WuXi Biologics, please visit: About Canbridge CANbridge Pharmaceuticals Inc. (HKEX:1228) is a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies for rare disease. CANbridge has a differentiated drug portfolio, with 3 approved drugs and a pipeline of 8 assets, targeting prevalent rare disease indications that have unmet needs and significant market potential. These include Hunter syndrome and other lysosomal storage disorders, complement-mediated disorders, hemophilia A, metabolic disorders, rare cholestatic liver diseases and neuromuscular diseases. The CANbridge Next-Generation Innovation and Process Development Facility is developing novel, potentially curative, gene therapies for rare genetic diseases, including Pompe disease, Fabry disease, spinal muscular atrophy (SMA), Duchenne muscular dystrophy (DMD) and other neuromuscular conditions, and collaborates with world-leading researchers and biotech companies. CANbridge global partners include: Apogenix, GC Pharma, Mirum, Wuxi Biologics, Privus, UMass Chan Medical School, the University of Washington School of Medicine and Scriptr Global. For more on CANbridge Pharmaceuticals Inc., please go to: Contacts Businessinfo@ MediaPR@ View original content: SOURCE WuXi Biologics 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
