Single-use Technologies
From Membrane Materials to Turnkey Solutions
Building a Safe, Compliant and Agile Single-Use Technology Platform for the Full Biopharmaceutical Workflow
Backed by our self-developed and in-house manufactured LeKrius® bioprocess film platform, LePure Biotech has established a full-value-chain single-use technology ecosystem spanning membrane materials, components, systems and validation services. Our robust R&D and manufacturing capabilities support customers across every stage, from process development and pilot trials to commercial-scale production.
As biopharmaceutical manufacturing evolves toward closed, flexible and automated workflows, LePure Biotech keeps upgrading its portfolio of single-use bioprocess bags, single-use process equipment and system integration expertise. We focus on core application scenarios including mixing systems, bioreactors, drug substance filling & freeze-thaw, formulation filling, PUPSIT systems and automated control platforms. We advance the co-development of consumables, equipment and bioprocesses to deliver highly tailored, high-efficiency bioprocess solutions for our clients.
Core Capabilities:
- Industry-Leading Bag Manufacturing Capacity：Our single-use storage bags feature a maximum working volume of 35,000 L to deliver stable performance for large-scale commercial manufacturing. Our product lineup addresses full-spectrum fluid handling demands spanning lab-scale milliliter volumes to multi-ten-thousand-liter industrial-grade systems.
- Outstanding Stability Under Extreme Process Conditions：All products are validated via long-term -80°C freeze-thaw cycling and drop tests. They withstand harsh process parameters to ensure safety and regulatory compliance throughout drug substance storage, transfer and freeze-thaw workflows.
- Customization & Compatibility Capability：Custom designs are available for compounding & storage bags, chromatography/TFF tube assemblies, PUPSIT modules and filling bag components. Compatible with mainstream industry process equipment platforms, our products cut customers’ expenses on compatibility validation.
- End-to-End System Integration Expertise：We deliver integrated solutions combining single-use consumables, fluid components and matching equipment for core unit operations: liquid storage, buffer/media preparation, cell culture, freeze-thaw and filling. This integrated approach accelerates process development and enhances cross-system compatibility for clients.
- Full-Lifecycle Regulatory & Supply Assurance：Supported by consistent large-scale manufacturing and reliable on-time delivery, we have won the Industry Best Delivery Award. We safeguard clients’ entire biopharmaceutical production chain to streamline process development and daily operational management with higher efficiency.
Explore More by Category
Storage & Transfer Solutions
From process buffers to high-value biologic drug substances, safe storage and transfer are critical to product quality.
Built on LeKrius® bioprocess film, LePure Biotech provides single-use storage and transfer solutions from 0.5 L to 4,000 L, covering 2D bags, 3D bags, support containers, transfer carts, and customized fluid paths. Standard and tailored configurations are available to support R&D, pilot-scale, and commercial manufacturing.
Mixing & Preparation Solutions
Media, buffer, and process solution preparation directly affects process stability and product consistency.
LePure Biotech provides integrated single-use mixing and preparation solutions, covering powder transfer bags, mixing bags, mixing equipment, and customized fluid paths. Designed for media preparation, buffer preparation, powder-liquid mixing, and process solution formulation, these solutions support efficient mixing, fast powder transfer, and sterile fluid transfer while helping reduce manual handling and cleaning validation requirements.
Single-Use Bioreactor Solutions
Bioreactor stability, scalability, and process consistency are essential to reliable cell culture and efficient biopharmaceutical manufacturing.
Built on the LePhinix™ single-use bioreactor platform, LePure Biotech provides integrated solutions covering single-use bioreactor bags, control systems, and supporting fluid assemblies. Designed for seed expansion, process development, pilot-scale studies, and commercial manufacturing, these solutions support feeding, sampling, harvest, and seamless connection with storage, mixing, and downstream purification workflows.
Drug Substance Freeze-Thaw Solutions
LePure Biotech provides single-use and temperature-controlled freeze-thaw solutions for biologic drug substances and critical intermediates. Covering freezing, storage, transportation, thawing, and transfer, these solutions help reduce process risks and support consistent product quality across different manufacturing scales.
Aseptic Filling & Dispensing Solutions
LePure Biotech provides single-use filling solutions covering filling bags, PUPSIT assemblies, customized fluid paths, and supporting process modules. Designed for sterile transfer from drug substance storage to filling equipment, these solutions help reduce on-site connections, improve efficiency, and lower contamination risk.
Fluid Management Assemblies
LePure Biotech provides standard and customized tubing assembly solutions for fluid transfer, aseptic connection, and disconnection across bioprocess workflows. Covering tubing, connectors, aseptic connectors, and custom assemblies, these solutions integrate with single-use bags and process equipment to support GMP-compliant closed fluid paths.