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LeKrius Single-Use Bioreactor 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.
Application
For culture of mammalian and insect cells (antibody, vaccine, cell therapy/gene therapy, etc.)
Advantages
- Independent formula, independent production, and controllable quality, ensuring sustainable supply chain of high-quality raw materials of film.
- Long-term contract and inventory of raw materials and related components, ensuring optimal supply and reliable delivery.
- The film recipe is optimized by the design of experiment. This ensures stable cell growth process control after short- and long-term storage of medium. Extractables data package is available.
- Biosafety of materials for single-use systems for pharmaceutical use, referenced and biologically evaluated by USP<87>, USP<88> and ISO10993, etc.
- The mechanical properties of the film are tested with reference to ASTM, ISO and other test standards, ensuring the operation safety and ease of use.