Your Reliable Partner for End-to-End Bioprocessing Solutions

LePure Biotech delivers high-performance single-use technologies and integrated bioprocessing solutions for the biopharmaceutical industry. From advanced film and bag assemblies to fluid management, equipment and validation services, we help accelerate drug development, ensure safety, and reduce costs, all backed by technical expertise and fast, reliable service.

  • Multiple state-of-the-art production facilities

  • Modern Class C cleanrooms ensuring GMP compliance

  • Robust quality management systems certified to ISO 13485 and ISO 9001:2015

  • Comprehensive validation services under ISO 17025, ISO 9001, and CNAS accreditation

  • Vertical integration and in-house production

  • Advanced materials, proprietary innovation, deep expertise in material science R&D

  • Reliable supply chain, global sites and efficient logistics

  • End-to-end bioprocess solution provider

Featured Products & Services

Single-use Bags

LeKrius® storage & mixing bags in 2D and 3D formats, available in 5 mL to 2,500 L.

LeDetic® bag with proprietary multi-layer film is designed for powders, with antistatic properties and low residue.

Custom bags designed to fit existing equipment, including media mixers and bioreactors.

Cryobag, filling bag, sampling bag, freeze & thaw bag.

Process Filtration

Comprehensive filter selections range from clarification to buffer and media filtration, with PES, PVDF, and PP filter capsules and cartridges.

Hydrophobic PTFE filters, hydrophobic PES filters offer extremely high porosity, low air resistance, and high flux. 

LeSiever® PES filters support sterile liquid filtration. Extreme™ PVDF filters offer high performance with low protein adsorption and high recovery.

Filter housing, connectors, holders

Tubing Assemblies

Le-Flex® TPE tubing excellent for sterile sealing and welding.

Platinum cured high purity silicone tubing; braided silicone tubing.

LeBrider® Customized Assembly offers a wide range of components, supported by ISO 9001 certified cleanrooms, dedicated assembly lines, and irradiation sterilization services.

Connectors, bottles, aseptic sampling tool set.

Cleanroom Solutions

Gloves, covers, gowns, and PPE for controlled environments.

Engineered for cleanrooms classified A/B/C/D in GMP and ISO stringent environments, validated detergents, wipes, mops.

Ready-to-use alcohols, hydrogen peroxide, and compound disinfectants including Hyamine and Peroxide (Types I & II).

Autoclave bags, autoclave bag sealer, cleanroom marker.

Equipment Solutions

LePhinix® Single-Use Bioreactor support everything from process development to commercial manufacturing

LeSiever® LFT-1010 filter integrity tester; Single-use bag integrity tester; Isolator gloves integrity tester.

LeMagmixer® is a cost-effective, high-performance single-use magnetic mixer.

Peristaltic pump, aseptic sealing & welder, disconnector.

Validation Services

Comprehensive E&L testing services, including USP <665> and BPOG protocols, to ensure material safety and compliance.

Comprehensive filter validation support, including bacterial retention testing, integrity testing, TOC, etc.

Surface challenge testing, contact time studies, and microbial reduction performance.

 

Viral clearance validation; visible particle analysis

Robust Quality

Quality is at the core of everything we do. Our quality system supports our customer to meet cGMP standards. It is certified to ISO 13485 and ISO 9001:2015. As a leading solution provider, we go beyond industry norms to deliver consistent, high-quality, and reliable products and services.

More about Validation Services