Table of Contents
Flexsafe® 2D & 3D Products
Flexsafe® bags ensure excellent and reproducible growth behavior of the most sensitive production cell lines. The optimization of the resin formulation and the complete control of our raw materials, the extrusion process and the bag assembly guarantee a consistent lot-to-lot cell growth performance.
To avoid cell growth issues that have been reported by several users of single-use bags1,2 and to ensure batch to-batch consistency, it is important to optimize and control the concentration of antioxidants. In close collaboration with polymer, additive and film suppliers, we developed a new polyethylene film, called S80. Applying a standardized cell growth assay3,4, the raw material composition and film formulation was optimized especially for critical upstream applications.
As a result, Flexsafe® bags are designed to excel thanks to:
|Optimized antioxidant package||=>||Excellent cell growth of the most sensitive cells|
|Use of pharmacopeia-listed antioxidants only||=>||Simplified toxicology assessment|
|Zero slipping agents||=>||No risk of interference due to these agents|
|Mechanical anti-blocking||=>||Reduces stickiness, facilitates extrusion and bag handling|
|Meaningful specifications and process control from polymer resin to finished bag||=>||Reliable and reproducible growth performance, well-characterized extractables profile|
1Gammell P., et al. The impact of lot-to-lot variability of disposable cell culture bags on cell growth during the scale-up of a mammalian production cell line. Cell Culture Engineering XIII, April 2012.
2Hammond M., et al. Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers. PDA J. Pharm. Sci. and Tech. 67 (2) 2013: 123-134.
3Jurkiewicz E., et al. Verification of a New Biocompatible Single-Use Film Formulation with Optimized Additive Content for Multiple Bioprocess Applications. Biotechnology Progress Early View. doi/10.1002/btpr.1934, first published 30 May 2014
4Fenge C., et al. Consistently superior cell growth achieved with new polyethylene film formulation. Bioprocess International Supplement, September 2014
Full Control of Manufacturing Process
The current industry practice of using resins or films based on trade names does not provide true control of polymer and additive formulations. Therefore, we established a strong collaboration with leading polymer, additive and film manufacturers to access and control the formulation of our polymer and additive package and to define and control the operating ranges for extrusion, welding and gamma-irradiation processes.
Flexsafe® is the first bag on the market that underlies complete control and traceability of all resins, additives and the entire manufacturing process:
- Film Polymers
- Extrusion Process
- Gamma Irradiation
Based on our unprecedented material science and process control approach, you can rely on excellent and reproducible growth behavior, even for your most sensitive cell lines. This has been confirmed by the recently published Dechema study* and biopharma companies worldwide using their specific cell lines. Further, no residual amounts of bDtBPP, a cytotoxic leachable, was identified in WFI extracts of Flexsafe® bags.
- Consistent growth and no aging effects after gamma irradiation
- Reliable growth performance of serum and protein-free media stored in Flexsafe® bags
* Eibl R., et al. Recommendation for leachable studies – Standardized cell culture test for the early identification of critical films for CHO cell lines in chemically defined culture media. DECHEMA Jan 2014
Flexsafe® meets your requirements for outstanding robustness and ease of use at all steps of your manufacturing process. The film’s strength and flexibility provide consistent performance and easy handling – even in the most stringent applications like cell culture, long-term storage or shipping of drug products.