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Unveiling the Future of Fucose-Based Glycoconjugate Manufacturing in 2025: Breakthroughs, Market Shifts, and the Path to Next-Gen Biotherapeutics. Can Industry Leaders Keep Up with Explosive Demand?

ByMason Dalton

2025-05-18
Unveiling the Future of Fucose-Based Glycoconjugate Manufacturing in 2025: Breakthroughs, Market Shifts, and the Path to Next-Gen Biotherapeutics. Can Industry Leaders Keep Up with Explosive Demand?

Fucose-Based Glycoconjugate Manufacturing: 2025's $Billion Biotech Surge Revealed

Table of Contents

Executive Summary: 2025 Landscape and Key Insights

The manufacturing landscape for fucose-based glycoconjugates is undergoing significant transformation in 2025, shaped by advancements in bioprocessing, expanding therapeutic applications, and growing demand for high-purity fucosylated compounds. Fucose, a deoxyhexose sugar, serves as a crucial building block in the synthesis of complex glycoconjugates, including therapeutic glycoproteins, vaccines, and diagnostic agents. The sector’s momentum is driven by both innovative biomanufacturing approaches and increased collaboration between biotechnology firms and established pharmaceutical manufacturers.

Key players such as Sigma-Aldrich (a subsidiary of Merck KGaA), Dextra Laboratories, and CarboSynth continue to expand their manufacturing capabilities to meet the rising demand for specialty fucose derivatives and glycoconjugate intermediates. These companies are investing in scalable enzymatic synthesis and fermentation-based platforms, which enable cost-effective, large-scale production with consistent product quality. For example, Sigma-Aldrich offers a range of fucose-based reagents and building blocks tailored to both research and industrial requirements.

Recent years have seen a surge in the adoption of chemoenzymatic synthesis, leveraging recombinant glycosyltransferases and engineered microbial strains for precise fucosylation. This approach addresses challenges associated with chemical synthesis, such as low yields and complex purification, while supporting the stringent regulatory standards required for pharmaceutical-grade glycoconjugates. Companies like GlycoTech Corporation specialize in custom synthesis and analytical services for fucosylated oligosaccharides, contributing to both R&D and GMP manufacturing pipelines.

In 2025, the competitive environment is further defined by strategic partnerships and acquisitions, as manufacturers seek to broaden their technology portfolios and geographic reach. The emergence of contract manufacturing organizations (CMOs) with expertise in glycoengineering—such as Rentschler Biopharma—enables biopharma clients to accelerate development timelines for fucose-containing biologics, including next-generation antibodies and cell therapies.

Looking ahead, the outlook for fucose-based glycoconjugate manufacturing remains robust, underpinned by the growing clinical relevance of fucosylated molecules in immuno-oncology, rare disease therapeutics, and vaccine adjuvants. Manufacturers are expected to further optimize upstream and downstream processes, enhance analytical characterization tools, and pursue sustainable production methods, positioning the sector for continued growth over the next several years.

Market Size & Growth Forecasts: 2025–2030 Outlook

The global market for fucose-based glycoconjugate manufacturing is entering a period of accelerated growth from 2025 onward, driven by expanding applications in pharmaceuticals, diagnostics, and biotechnology. Fucose, a deoxyhexose sugar, is a critical component in various glycoconjugates, notably in monoclonal antibodies (mAbs) where its presence or absence (afucosylation) can significantly impact therapeutic efficacy. The rising demand for advanced biologics and biosimilars is a key catalyst for market expansion, with biopharmaceutical companies increasingly prioritizing glycoengineering to enhance clinical outcomes.

Leading manufacturers have ramped up their investments in fucose-related technologies. For example, Roche and Genentech (a member of the Roche Group) have ongoing initiatives to optimize glycosylation profiles in antibody production, recognizing the importance of fucose in modulating antibody-dependent cell-mediated cytotoxicity (ADCC). Additionally, Biogen and Amgen are advancing manufacturing platforms that facilitate the precise incorporation or removal of fucose residues, improving product consistency and efficacy.

Technological advancements are further fueling the market outlook. New cell line engineering techniques, such as CRISPR-based genome editing and proprietary glycoengineering platforms, are enabling manufacturers to control fucosylation with high precision. Lonza and Sartorius are providing contract development and manufacturing organization (CDMO) services, supporting both large and emerging biotech firms in scaling up fucose-optimized biologics.

In terms of regional dynamics, North America and Europe are expected to retain significant market shares through 2030, owing to robust investment in biopharmaceutical R&D and established regulatory frameworks for advanced therapies. However, rapid expansion is also anticipated in Asia, particularly in China and South Korea, where companies such as WuXi Biologics and Samsung Biologics are scaling up manufacturing capacity and adopting state-of-the-art glycoengineering solutions.

Looking ahead, the fucose-based glycoconjugate manufacturing market is projected to see double-digit compound annual growth rates (CAGR) over the 2025–2030 period, underpinned by the convergence of scientific innovation, regulatory support for novel biologics, and expanding clinical pipelines. The next few years will likely bring strategic collaborations, capacity expansions, and the commercialization of new fucose-optimized therapeutic agents, further consolidating the market’s upward trajectory.

Core Technologies Shaping Fucose-Based Glycoconjugates

Fucose-based glycoconjugates, molecules where fucose is covalently attached to proteins or lipids, are gaining momentum in pharmaceutical and biotechnology sectors due to their roles in cell signaling, immune modulation, and therapeutic targeting. As of 2025, several core technologies are shaping manufacturing approaches, emphasizing precision, scalability, and regulatory compliance.

One of the most transformative trends is the adoption of enzymatic glycoengineering for the site-specific incorporation of fucose onto biomolecules. Enzyme-based systems, such as fucosyltransferases, enable controlled synthesis of fucosylated oligosaccharides and glycoproteins. Companies like New England Biolabs offer recombinant fucosyltransferases and related enzymes, facilitating in vitro fucosylation with high selectivity and reduced side products. This approach is increasingly favored over traditional chemical synthesis due to its mild reaction conditions and compatibility with complex biologics.

Advancements in microbial and mammalian cell line engineering are central to scalable manufacturing. For instance, Lonza and Sartorius have invested in glycoengineered CHO (Chinese Hamster Ovary) cell lines capable of precise glycan modulation, including fucosylation patterns tailored for therapeutic antibodies. These platforms allow for reproducible batch production and meet stringent biopharmaceutical manufacturing standards. The ongoing optimization of cell culture media and feeding strategies further supports robust fucose incorporation, ensuring product consistency at industrial scales.

In parallel, continuous bioprocessing technologies are being integrated into fucose-based glycoconjugate manufacturing. Companies such as GE HealthCare (Cytiva) are providing modular bioreactors and purification systems that support seamless, automated workflows. These systems enable real-time monitoring and control of glycosylation profiles, improving product quality and reducing production costs—a key advantage as the market for glycoengineered therapeutics expands.

Analytical advancements are also crucial. High-resolution mass spectrometry and capillary electrophoresis, provided by firms like Thermo Fisher Scientific, allow manufacturers to characterize fucosylation at the structural level. This ensures regulatory compliance and supports the development of biosimilars with matched glycan profiles.

Looking ahead to the next few years, further integration of synthetic biology, machine learning for process optimization, and digital twins for manufacturing predictability are expected. These innovations will enhance yield, flexibility, and regulatory traceability, positioning fucose-based glycoconjugates as a cornerstone in next-generation biotherapeutics manufacturing.

Emerging Applications in Biopharma and Glycobiology

Fucose-based glycoconjugate manufacturing is poised for significant advancements in 2025, propelled by the expanding biopharmaceutical and glycobiology sectors. Fucose, a critical monosaccharide, is increasingly recognized for its role in modulating immune responses, cell signaling, and therapeutic efficacy, particularly in monoclonal antibodies (mAbs) and vaccine development. The demand for fucose-engineered glycoconjugates is being driven by the need to enhance antibody-dependent cellular cytotoxicity (ADCC) and to reduce immunogenicity in therapeutic proteins.

Major biopharmaceutical manufacturers are actively developing and optimizing processes for the controlled incorporation or removal of fucose moieties from glycoproteins. For example, Roche has advanced the use of glycoengineering platforms to produce afucosylated antibodies with improved therapeutic profiles, as seen in their oncology pipeline. Similarly, Genentech, a member of the Roche Group, utilizes proprietary cell lines and expression systems designed to manipulate fucosylation patterns for next-generation antibody therapeutics.

Bioprocess technology providers are also innovating in cell line engineering and fermentation control, with companies such as Sartorius supplying bioreactor systems and process optimization tools that enable precise modulation of glycosylation, including fucosylation. These platforms are crucial for ensuring batch-to-batch consistency and regulatory compliance in the manufacture of complex glycoconjugates. Furthermore, Merck KGaA (MilliporeSigma in the US and Canada) offers a suite of analytical solutions specifically tailored for the characterization of glycan structures, supporting the quality assurance of fucose-modified biopharmaceuticals.

Emerging applications in glycobiology are also shaping the manufacturing landscape. Companies such as Glycotope are leveraging unique glycoengineering technologies to generate highly defined fucose-based glycoconjugates, targeting not only cancer but also autoimmune and infectious diseases. Their platforms enable the customization of glycan structures, opening new avenues for personalized medicine and targeted therapeutics.

Looking ahead, the next few years will likely see further integration of synthetic biology and enzymatic synthesis methods in fucose-based manufacturing, with increased collaboration between technology developers and pharmaceutical companies. The focus will be on scalable, cost-effective processes that meet stringent regulatory standards while expanding the repertoire of glycoengineered products. With the global biopharma sector’s emphasis on innovation, fucose-based glycoconjugates are set to play a pivotal role in the next wave of therapeutic and diagnostic breakthroughs.

Competitive Analysis: Leading Manufacturers and Innovators

The manufacturing landscape for fucose-based glycoconjugates is rapidly evolving in 2025, propelled by advances in biotechnology, bioprocessing, and increasing demand from pharmaceutical and nutraceutical industries. Fucose, a hexose deoxy sugar, plays a crucial role in biological recognition processes, making its incorporation into glycoconjugates valuable for both therapeutic and diagnostic applications. The competitive field is defined by a blend of established biochemical manufacturers and innovative biotechnology firms, each adopting distinct strategies to enhance production efficiency, product purity, and scalability.

Among the global leaders, DSM continues to invest in microbial and enzymatic synthesis of rare sugars, including fucose derivatives, supporting both R&D and commercial-scale production. The company leverages its expertise in fermentation and downstream processing to supply high-purity fucosylated compounds for pharmaceutical and nutritional use. Similarly, DuPont Nutrition & Health (now part of IFF) has established robust platforms for the production of human milk oligosaccharides (HMOs) such as 2’-fucosyllactose (2’-FL), using proprietary fermentation technologies aimed at infant formula enrichment and functional food sectors.

Innovators like Glycom (a part of DSM) have pioneered scalable microbial fermentation processes for HMOs, with a focus on fucosylated oligosaccharides. Their manufacturing capabilities have been expanded to meet rising global demand, particularly in Europe, North America, and Asia. In parallel, Jennewein Biotechnologie (a part of Chr. Hansen) has continued to expand its production of fucose-containing glycoconjugates, leveraging genetically optimized bacterial strains to achieve high yields and cost-effectiveness.

On the innovation front, Evolva is harnessing synthetic biology for the scalable manufacture of specialty sugars, including fucose derivatives, with an emphasis on sustainability and precision. Their platform enables the production of tailor-made glycoconjugates for pharmaceutical and nutraceutical clients, positioning them as a key player in the high-value segment of this market. Meanwhile, Novozymes is advancing enzymatic processes for fucosylation, enabling the production of structurally specific glycoconjugates for therapeutic applications.

Looking ahead, the competitive landscape will likely see further consolidation and collaboration, as major players seek to combine fermentation scale, strain engineering, and downstream process innovation. Regulatory clearances, particularly for food and pharmaceutical applications, will remain a focal point, with companies investing in compliance and quality assurance to secure market access. With demand for fucose-based glycoconjugates anticipated to rise—driven by trends in personalized medicine, functional foods, and advanced therapeutics—leading manufacturers are expected to expand capacity, diversify product portfolios, and accelerate innovation over the next several years.

Supply Chain Dynamics and Raw Material Sourcing

The supply chain for fucose-based glycoconjugate manufacturing in 2025 is characterized by increasing complexity and strategic shifts, as demand for fucosylated oligosaccharides and related biotherapeutics accelerates. Fucose, a key monosaccharide in various glycoconjugates, is primarily sourced through microbial fermentation or extraction from natural sources. In recent years, industry players have focused on optimizing upstream raw material sourcing and downstream processing to ensure both scalability and regulatory compliance.

Leading suppliers such as DSM and Danisco have expanded fermentation capacity for L-fucose and related sugars, leveraging genetically engineered strains of Escherichia coli and other microbes to provide high-purity substrates for pharmaceutical and nutraceutical applications. This shift toward biotechnological production is driven by both sustainability concerns and the need for consistent quality required by regulatory authorities. These companies often engage in strategic partnerships with bioprocess equipment manufacturers to enhance fermentation yield and downstream purification efficiency.

On the extraction front, companies such as Merck (Sigma-Aldrich) provide research and GMP-grade L-fucose sourced from seaweed and other marine biomass, although this method faces challenges in scalability and batch-to-batch variability. As a consequence, the trend toward precision fermentation is expected to further dominate over the next few years, as suppliers respond to pressure from pharmaceutical clients for traceable, contaminant-free raw materials.

Supply chain resilience is becoming a central concern, particularly after pandemic-induced disruptions exposed vulnerabilities in sourcing rare sugars and specialized enzymes. To mitigate risk, manufacturers are diversifying supplier bases and investing in regional production hubs. For example, Evonik Industries has announced investments into bioprocess infrastructure in Europe and Asia, aiming to shorten supply lines and improve material availability for glycoconjugate synthesis.

Looking ahead to the next few years, the market outlook suggests continued investment in upstream biomanufacturing, digital supply chain management, and vertical integration. Companies are exploring blockchain-based traceability systems to assure clients of the provenance and quality of fucose derivatives. Innovation in enzyme engineering and microbial strain development is expected to enhance yields and lower costs, with several biopharmaceutical partnerships already announced for 2025 and beyond. As regulatory scrutiny tightens, documentation and real-time monitoring along the entire supply chain will be critical factors for maintaining competitiveness in fucose-based glycoconjugate manufacturing.

The regulatory landscape for fucose-based glycoconjugate manufacturing is rapidly evolving in 2025, shaped by the increasing deployment of these molecules in vaccines, therapeutics, and diagnostics. Global authorities, especially the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), are intensifying their scrutiny of glycan-related critical quality attributes and manufacturing process controls.

A significant regulatory trend is the demand for robust characterization and traceability of fucose-containing glycan structures, which are pivotal for product efficacy and safety. For example, regulatory submissions for monoclonal antibodies and vaccines now require detailed glyco-profiling, emphasizing the presence and linkages of fucose residues, due to their impact on antibody-dependent cellular cytotoxicity (ADCC) and immunogenicity. This has led manufacturers to invest in advanced analytics for glycan mapping and to validate process consistency from raw material sourcing through to final product release.

In 2025, compliance challenges center around the complexity of biological manufacturing and the introduction of novel biotechnological platforms. Companies such as Genentech and F. Hoffmann-La Roche Ltd—leaders in antibody-based therapeutics—are adapting their quality systems to comply with new guidance on controlling fucosylation levels in their products. The EMA’s updated guidelines on biologics, for instance, specifically call for the quantification and control of alpha-1,6-fucosylation in therapeutic proteins, requiring enhanced batch-to-batch consistency and more rigorous documentation.

Another compliance challenge arises from the increasing use of synthetic and recombinant fucose derivatives. Manufacturers like DSM and Danisco (a part of DuPont) are scaling up the production of fucose and related oligosaccharides, necessitating new regulatory approaches to ensure the identity, purity, and safety of these ingredients in both pharmaceutical and food applications. The U.S. FDA has issued draft guidance on the use of novel oligosaccharides, including fucosylated compounds, in infant formula and medical foods, requiring detailed dossiers on safety and manufacturing controls.

Looking forward, the next few years are expected to bring greater harmonization of regulatory requirements globally, particularly on issues such as analytical method validation for glycan analysis and the traceability of manufacturing changes that could affect fucosylation patterns. As the adoption of continuous manufacturing and in-line analytical technologies grows, regulators are likely to update Good Manufacturing Practice (GMP) expectations, with a focus on real-time release testing and digital batch records.

Industry organizations such as Biotechnology Innovation Organization (BIO) and International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) are actively engaging with regulators to shape policy, aiming to ensure that compliance burdens do not stifle innovation in fucose-based glycoconjugate development, while maintaining high standards of patient safety and product efficacy.

Investment Hotspots and M&A Activity

The landscape of investment and M&A activity in fucose-based glycoconjugate manufacturing is evolving rapidly as of 2025, driven by the growing interest in glycoengineering, precision therapeutics, and specialty ingredients. The heightened demand for fucose-containing oligosaccharides and glycoconjugates—especially for pharmaceutical, nutraceutical, and infant nutrition applications—has made this sector a focal point for both strategic investments and consolidation efforts.

A key driver is the surge in demand for human milk oligosaccharides (HMOs), particularly 2’-fucosyllactose (2’-FL), which has led to significant expansion by established manufacturers. For example, DSM-Firmenich and DuPont (now part of IFF) have made substantial capital investments in scaling up biotechnological production of fucose-rich HMOs to serve the growing infant formula market. Similarly, Chr. Hansen has continued to expand its fermentation capabilities for specialty glycoconjugates, citing robust market projections for fucosylated products.

On the M&A front, the past two years have seen a wave of acquisitions as large ingredient and biotech players seek to secure technological capabilities and market share in fucose-based glycoconjugates. Notably, Carlsberg Group, through its biotech subsidiary Unibio, acquired a minority stake in Glycom, a Denmark-based pioneer in fucosylated HMO manufacturing. This move follows the earlier acquisition of Glycom by Nestlé in 2020, signaling continuing consolidation intent among major players.

In Asia, investment is accelerating, with companies such as Yakult Honsha and Maruha Nichiro increasing R&D expenditure and forming joint ventures to access microbial and enzymatic production platforms for fucosylated glycoconjugates. These collaborations are expected to mature into commercial-scale operations by 2026, leveraging the region’s expertise in fermentation and bioprocess scale-up.

  • Strategic partnerships are also on the rise; Evonik Industries has entered into agreements with several biotech startups to co-develop advanced fucosylation technologies, with pilot programs projected to move toward commercial deployment within the next two years.
  • Venture capital activity remains strong, with early-stage firms focusing on enzymatic synthesis and precision fermentation attracting funding rounds from corporate venture arms of established life sciences companies.

Looking ahead, competitive pressure is expected to intensify as new entrants and technology-driven startups emerge, particularly those leveraging synthetic biology and green chemistry. The next few years will likely see further M&A activity, cross-sector alliances, and capital infusions aimed at scaling production, reducing costs, and meeting regulatory requirements for fucose-based glycoconjugates in food, pharma, and cosmetics. The sector’s high growth potential positions it as an investment hotspot well into the latter part of the decade.

Barriers to Scale and Commercialization Strategies

Fucose-based glycoconjugate manufacturing is at a pivotal point in 2025, facing several barriers to scale yet also witnessing the emergence of innovative commercialization strategies. One of the principal challenges remains the complexity of producing fucosylated compounds with precise structural fidelity. Traditional chemical synthesis is often inefficient and costly due to multiple protection and deprotection steps, while enzymatic and fermentation-based methods, though promising, require further optimization for large-scale industrial deployment.

A significant technical barrier is the limited availability and high cost of key enzymes such as fucosyltransferases. These enzymes are essential for the site-specific incorporation of fucose into glycans but are difficult to express in high yield and activity. Companies like Novozymes are actively working to engineer more robust and scalable enzyme production systems, with advances in microbial expression platforms and process optimization expected in the next few years.

Bioprocessing infrastructure also presents a scaling challenge. The current bioreactor systems and downstream purification protocols require adaptation to accommodate the unique demands of fucose-based products. Evonik Industries AG, for example, is investing in modular, flexible manufacturing facilities designed to quickly switch between different glycan and glycoconjugate production campaigns, thereby reducing downtime and increasing responsiveness to market demand.

Raw material sourcing is another bottleneck. L-fucose, the key monosaccharide, is still relatively expensive and produced at limited scale. Efforts by suppliers like Carbosynth and Megazyme are focused on improving microbial and enzymatic synthesis routes for L-fucose, aiming to lower costs and secure more reliable supply chains by 2026.

On the commercialization front, strategic partnerships and licensing agreements are accelerating market entry. Several biopharmaceutical companies are entering collaborations with academic institutions and technology developers to access novel fucosylation technologies. For example, Glycotope has partnered with manufacturing organizations to fast-track the scale-up of therapeutic glycoproteins featuring targeted fucosylation, leveraging proprietary cell line platforms for improved yields and product consistency.

Looking ahead, regulatory considerations are shaping manufacturing and commercialization strategies. With increasing interest in fucose-modified biologics, organizations such as European Medicines Agency are expected to clarify guidance on quality control and comparability for glycoengineered products, which will be critical for successful approval and market adoption over the next several years. Overall, the sector’s outlook hinges on continued innovation in bioprocessing, strategic collaborations, and evolving regulatory frameworks to unlock the full commercial potential of fucose-based glycoconjugates.

Future Outlook: Vision 2030 and Industry Game-Changers

As the biopharmaceutical and functional ingredient sectors continue to expand, the manufacturing of fucose-based glycoconjugates is poised for significant transformation by 2030. Fucose, an essential monosaccharide in many bioactive glycans, is increasingly recognized for its roles in immunomodulation, cell signaling, and as a critical component in therapeutic glycoproteins. The current landscape in 2025 is shaped by advances in fermentation technology, enzyme engineering, and downstream processing, setting the stage for industry game-changers over the next five years.

Leading bioprocess manufacturers are scaling up microbial and enzymatic production of fucosylated oligosaccharides, particularly 2’-fucosyllactose (2’-FL), which has witnessed rapid commercialization due to its health benefits in infant nutrition and adult gut health. Companies such as DSM-Firmenich and DuPont (now part of IFF Health & Biosciences) have expanded their production capacities for HMOs (human milk oligosaccharides), leveraging genetically engineered microbial strains to achieve high efficiency and purity.

In the therapeutic domain, fucose’s role in antibody glycosylation—especially afucosylated antibodies that enhance antibody-dependent cellular cytotoxicity (ADCC)—has become a manufacturing priority. Roche and Genentech are optimizing cell line engineering to control fucosylation levels, aiming to increase the efficacy of next-generation monoclonal antibodies. Meanwhile, Lonza and Sartorius are providing modular bioreactor platforms and integrated process solutions to facilitate scalable manufacturing of fucose-rich glycoconjugates.

Looking toward 2030, industry stakeholders anticipate a convergence of synthetic biology, precision fermentation, and continuous manufacturing to enable cost-effective, sustainable production. For example, Evonik Industries is investing in advanced bioprocessing for specialty carbohydrates, including fucosylated glycans, targeting pharmaceutical and functional food markets. Additionally, regulatory clarity and harmonization—led by organizations like the European Medicines Agency and U.S. Food & Drug Administration—will streamline market entry for novel fucose-based products, fostering innovation.

  • Expansion of cell-free and cell-based synthesis platforms is expected to reduce production costs and environmental impact.
  • Strategic collaborations between biotech firms and ingredient manufacturers will accelerate the commercialization pipeline for novel fucosylated structures.
  • Personalized medicine and nutrition trends are likely to drive tailored fucose-based glycoconjugate development, especially for rare disease therapies and microbiome modulation.

In summary, the next five years will be pivotal for fucose-based glycoconjugate manufacturing, with advances in bioprocessing, regulatory alignment, and market demand positioning the segment as a focal point for both therapeutic and nutritional innovation by 2030.

Sources & References

The Future of Manufacturing in 2025: How AI Is Transforming Industry

ByMason Dalton

Mason Dalton is a fervent writer and thought leader in the fields of new technologies and financial technology (fintech). He earned his Bachelor of Science in Information Technology from the prestigious University of Wisconsin, where his passion for innovation was ignited. Following his academic pursuits, Mason honed his expertise as a financial analyst at Kraken Holdings, a company renowned for its cutting-edge approach to cryptocurrency and investment solutions. With a keen eye for emerging trends and a deep understanding of the intersection between technology and finance, Mason's work aims to demystify complex concepts and make them accessible to a wider audience. His analytical insights continue to shape the conversation around the future of financial services.

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