LePure Biotech products

In upstream cell culture or microbial fermentation, sampling is an inevitable and extremely critical step to monitor the parameters to ensure stability, safety and controllability of the whole culture process. The Single Use Sterile Sampling Bags perfectly combine with the sampling system, effectively avoiding the risks of cross contamination in the sampling process. You can sample aseptically and safely at any stage of the process for reliable process monitoring.

Made with LeKrius^TM Single Use Biopharma Film, LeKrius^TM3D Storage Bag has excellent anti-puncture, anti-twisting and other physical properties. The selected optimal production process parameters ensure the firmness of welding edge of the bag body, and minimize the risk of liquid leakage. The excellent gas barrier property reduces the permeability of CO₂ and O₂, etc., thus ensuring the quality of the feed liquid. Its excellent chemical compatibility and biological compatibility ensure a wide process application. with highly customizable, LePure’s bag has flexible and diverse configurations with Luer connection, CPC quick connection, AQG sterile connector, Tri-Clamp sanitary connector, etc,  the inlet and outlet tubing,  multiple sampling methods, such as needless sampling, Luer sampling or sampling bag.

With the development of the bio-pharmaceutical industry, more and more customers choose single-use bioreactors for shortening the product preparation cycle, avoiding cross-contamination, cleaning validation, etc. The stability and consistency of single-use bioreactor bags are essential to ensure the safety of the culture process. Additionally, new challenges arise with the increasing use of single-use bioreactor bags in scale-up and commercial production of biopharmaceuticals. LePure Biotech aims to improve stability and consistency of product quality as well as supply assurance with a new polyethylene film-based bioreactor bag. The new bioreactor bag is produced in a local Grade C + A manufacturing plant, aiming to provide high-quality, single-use bioreactor bags that can be customized according to the actual needs of customers.

Independently formulated and produced by LePure, LeKrius^TM Film is a single use film specially used for the biopharmaceutical process, and its main material is LDPE-EVOH-ULDPE. with a thickness of 0.4 mm, The film adopts themulti-layer co-extrusion technology, its tensile strength, heat-sealing strength, anti-puncture and other physical properties have been improved by the continuing improvements. The film has passed complete biosafety certification and perfect validation documents, ensuring a good cell culture performance. LeKrius™ film has a stable supply chain, excellent quality and reliable production capacity.

With the development of biopharmaceutical industry, bioreactors are increasingly used in upstream biopharmaceutical process, including antibodies, vaccines, cells, and gene therapy. LePhinix bioreactors is an advanced single-use bioprocess platform providing upstream process solutions to support process development and scale-up. Its hardware, software, and consumables offer superior performance to meet R & D, pilot-scale, clinical application, and commercial production requirements. LePhinix system can be operated flexibly and controlled precisely. The system is customizable according to the actual process requirements of customers.