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Cision Canada
4 days ago
- Business
- Cision Canada
WuXi Biologics' WuXiUP™ Accomplishes Automated Continuous Drug Substance Production at Pilot-Scale
Building on its success in developing continuous production at pilot-scale with the WuXiUP™ platform, WuXi Biologics has further enhanced the technology to achieve automated continuous drug substance (DS) manufacturing at pilot-scale. This advancement integrates industry-leading technologies, including membrane chromatography and automated control systems, along with iterative enhancements to Process Analytical Technology (PAT). The WuXiUP™ automated continuous production platform will deliver greater value as it boosts manufacturing efficiency and product quality, enabling clients to accelerate the journey of their innovative therapies from development to commercialization. SHANGHAI, Aug. 12, 2025 /CNW/ -- WuXi Biologics ( a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that its intensified perfusion culture process platform, WuXiUP™, has achieved end-to-end, fully automated continuous drug substance（DS）production at pilot scale. The automated continuous production platform will be deployed across the company's major GMP facilities, offering clients greater efficiency and flexibility to accelerate the journey of their innovative therapies from development to commercialization. By fully integrating an automated system, the continuous production platform enables non-stop 24/7 operation, which minimizes manual intervention, reduces quality risks, and enhances manufacturing efficiency. In upstream processes, WuXiUP TM has accomplished exceptional performance: 24 days of continuous cell culture yields a total output that exceeds 110 g/L, with a peak daily yield of 7.6 g/L. For downstream purification, WuXiUP™ incorporates a two-step, high-efficiency membrane chromatography system. Compared to traditional resin-based stationary phases, this technology enables faster mass transfer, delivering a 5- to 10-fold increase in productivity. To strengthen quality control throughout downstream continuous purification, WuXiUP™ employs advanced, iteratively improved Process Analytical Technology (PAT), which provides real-time monitoring and feedback on critical parameters in Harvested Clarified Cell Culture Fluid (HCCF), including protein purity, concentration, pH, and conductivity. When integrated with the automated closed-loop control system, the technology utilizes Residence Time Distribution (RTD) analysis to intelligently divert out-of-spec samples, significantly enhancing manufacturing procedure control. Dr. Chris Chen, CEO of WuXi Biologics, commented: "The WuXiUP™ platform has already proved its technical maturity and viability in commercial manufacturing. And now it has reached another significant milestone: accomplishing fully automated continuous DS production at pilot scale. Such achievements underscore WuXi Biologics' steadfast dedication to furthering technological innovation, and advancing the standards for digitalization and automation in biopharmaceutical R&D and manufacturing — both of which are critical capabilities to improve quality and accelerate timelines. With our deep technical expertise and extensive track record, WuXi Biologics remains committed to enabling our global clients to speed drug development more efficiently, benefiting patients worldwide." About WuXiUP TM WuXiUP TM is an intensified perfusion culture process developed as a next-generation biomanufacturing solution that provides high-yield, high-quality drug products while being highly flexible and cost-effective. Compared to traditional fed-batch and perfusion processes, WuXiUP TM enables the manufacturing of diverse pharmaceutical proteins, including mAb, bispecific antibody, fusion protein, and other recombinant protein, with 5–20× higher productivity. This performance advantage is particularly notable when scaling to 1,000–2,000 L using single-use bioreactors, where it achieves productivity levels comparable to those of traditional 10,000–20,000 L stainless steel bioreactors. The WuXiUP TM platform has enabled one molecule to receive BLA approval and 11 others to receive IND approvals.
Yahoo
16-06-2025
- Business
- Yahoo
WuXi AppTec Recognized by Extel 2025 Asia Executive Team Rankings with Top Honors
SHANGHAI, June 16, 2025 /PRNewswire/ -- WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life science industries, has been recognized among the Top 10 "Most Honored Companies" in new rankings from Extel (formerly known as Institutional Investor). WuXi AppTec was chosen from more than 1,600 companies across 18 industries in Extel's 2025 Executive Team rankings for companies in Asia (ex-Japan/ANZ). This distinction, which is based on a survey of investment professionals, is a testament to the Company's success in advancing the highest quality of patient care by empowering its customers to deliver innovative therapies worldwide. Notably, WuXi AppTec achieved first-place rankings in the Healthcare, Pharma & Biotech sector in the following categories: "Best CEO," "Best CFO," "Best Company Board," "Best IR Program" and "Best ESG Program." This recognition underscores how WuXi AppTec's unique Contract Research, Development and Manufacturing Organization (CRDMO) model continues to drive sustainable business growth and enable the industry, patients and customers, creating lasting value to shareholders. Extel's annual Executive Team survey is a trusted benchmark for global capital markets. More than 6,300 portfolio managers and analysts at 1,324 institutions (including 1,167 buy-side firms and 157 sell-side firms) participated in this year's survey, which nominated and rated 1,668 companies and 2,367 executives across 18 industries in Asia (ex-Japan/ANZ). WuXi AppTec enables customers to deliver cutting-edge care to patients by prioritizing customer needs, embracing scientific innovation, and capturing new molecule opportunities. The company's unique CRDMO model provides seamless support across the entire drug development process, lowering the cost of both research and deployment, while adhering to the highest quality standards. About WuXi AppTec As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the fourth consecutive year in 2024 and its open-access platform is enabling around 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated." View original content: SOURCE WuXi AppTec 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
Times of Oman
21-02-2025
- Business
- Times of Oman
India becoming an attractive option for global pharmaceutical supply chain: Macquarie Report
New Delhi: India's Contract Research, Development, and Manufacturing Organization (CRDMO) industry is on a strong growth trajectory, with its market size expected to double from the current approx. USD 7 billion to approx. USD 14 billion by 2028, according to a report by Macquarie Equity Research. The industry is projected to grow at a 14 per cent compound annual growth rate (CAGR), driven by rising pharmaceutical outsourcing, regulatory support, and global supply chain restructuring. It said, "the Indian CRDMO industry, currently valued at around USD 7bn, is set to deliver a 14 pc CAGR to around USD 14bn by 2028. Furthermore, we believe that regulatory tailwinds, such as the US Biosecure Act, could accelerate this growth to a high-teens CAGR" CRDMO is a third-party company that provides services to pharmaceutical and biotechnology companies. CRDMOs help with all aspects of drug development and manufacturing. The report highlighted that India's CRDMO sector is at an inflexion point, benefiting from drug pricing pressures and geopolitical factors. As global pharmaceutical companies look for cost-effective and reliable manufacturing partners, India is emerging as a preferred destination for small-molecule drug development and production. Additionally, the report says that regulatory measures such as the US Biosecure Act could accelerate growth to a high-teens CAGR, potentially pushing the industry to USD 22 billion by 2030. These factors are leading to a shift in global pharmaceutical supply chains, reducing reliance on China. The broader Asia-Pacific pharmaceutical CDMO sector was valued at over USD 50 billion in 2023. This expansion is being driven by cost-effective manufacturing, increasing outsourcing trends, and geopolitical risks that are prompting companies to diversify supply chains. While China remains the largest player, India is increasingly becoming the preferred choice for pharmaceutical outsourcing due to multiple factors. Indian CDMOs offer a cost advantage of 30-40% compared to Western counterparts, making them an attractive option for global pharmaceutical firms. The country also has a strong regulatory track record, with approvals from global agencies such as the USFDA and EMA. Moreover, India's expertise in Active Pharmaceutical Ingredients (APIs), Highly Potent APIs (HPAPIs), and speciality chemicals further strengthens its position in the global pharmaceutical supply chain. With a favourable regulatory environment, cost advantages, and increasing global demand for outsourced pharmaceutical manufacturing, India's CRDMO sector is well-positioned for sustained growth in the coming years.
