中文From Film Materials to Turnkey Single-Use Solutions
Building a Safe, Compliant and Flexible Single-Use Technology Platform for the Entire Biopharmaceutical Workflow
Leveraging our self-developed and in-house manufactured LeKrius® bioprocess film platform, LePure Biotech has built a full-industry-chain single-use technology platform encompassing film substrates, assemblies, systems and validation services. Backed by robust R&D and manufacturing capabilities, we support customers throughout all stages from process development and pilot scale-up to commercial production.
As biopharmaceutical processes evolve toward closed, flexible and automated operation, LePure Biotech continuously strengthens our competencies in single-use bioprocess bags, single-use process equipment and system integration. We focus on core application scenarios including mixing systems, bioreactors, bulk drug filling & freeze-thaw processing, formulation filling, PUPSIT systems and automated control platforms. Through collaborative development of consumables, equipment and processes, we deliver better-aligned, higher-efficiency bioprocess solutions for our customers.
Core Competitive Advantages：
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Industry-Leading Bag Fabrication Capacity：Our single-use bioprocess bags are available in a maximum working volume of 35,000 L, delivering robust reliability for large-scale commercial manufacturing. We fully address full-spectrum fluid handling requirements spanning lab-scale milliliter volumes through multi-thousand-liter industrial production scales.
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Exceptional Process Robustness Under Harsh Conditions：All products are validated via long-term −80 °C freeze-thaw cycling and drop impact testing. Engineered to withstand rigorous process environments, they ensure regulatory compliance and product safety throughout bulk drug substance storage, transfer and freeze-thaw workflows.
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Highly Customizable Configuration Compatibility： Custom design services are offered for bioprocess storage bags, chromatography & ultrafiltration tubing assemblies, PUPSIT assemblies and filling bag components. Tailored to mainstream industry equipment platforms, our solutions minimize customers’ compatibility qualification expenses.
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End-to-End System Integration Expertise： We deliver synergistic turnkey packages integrating single-use consumables, fluidic assemblies and matched equipment for core workflows including buffer & media preparation, bulk storage, cell culture, freeze-thaw and filling operations. This elevates process development efficiency and overall system interoperability for our partners.
- Full-Lifecycle Regulatory & Supply Assurance： Backed by mature mass production and dependable order fulfillment capabilities, we have been honored with the Industry Best Delivery Award. We safeguard the entire biomanufacturing value chain for customers, enabling streamlined process development and optimized operational governance.
Product Range
Single-Use Liquid Storage System
From process buffers to high-value bulk biopharmaceutical drug substances, secure and reliable storage and transfer serve as a critical foundation for ensuring product quality.
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Single-Use Liquid Preparation System
LePure possesses capabilities in the design, integration and manufacturing of single-use liquid preparation systems. We can deliver standardized and customized solutions for mixing systems, feeding systems and single-use fluid paths tailored to customers’ process requirements, enabling integrated synergy among consumables, equipment and processes.
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Single-Use Bioreactor
Leveraging the LePhinix™ single-use bioreactor platform, LePure delivers holistic solutions ranging from single-use bioreactor bags and control systems to supporting fluidic components. Our offerings address demands across various stages, including seed expansion, process development, pilot-scale scale-up and commercial manufacturing.
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Drug Substance Freeze-Thaw
LePure drug substance freeze-thaw solutions are built upon proprietary LeKrius® bioprocess films and the LeThenea™ freeze-thaw platform. We offer integrated bag-and-container single-use flexible freeze-thaw systems as well as reusable temperature-controlled freeze-thaw systems, covering the full process workflow from freezing storage, transportation, thawing to liquid transfer. Our solutions help customers mitigate risks throughout freeze-thaw cycles and ensure consistent product quality.
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Formulation & Filling
Leveraging our development capabilities for single-use filling systems, LePure supports customized integration of filling bags, PUPSIT assemblies, fluid paths and matching process modules, and can deliver standardized and tailored solutions in accordance with customers’ process requirements.
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Aseptic Connection & Disconnection
Backed by mature capabilities in fluid system design and assembly, LePure supplies standardized products as well as custom tubing assembly services to accommodate diverse process routes, equipment platforms and production scales, enabling efficient interconnection between single-use systems and process equipment.