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Is your Single-Use Solution Ready for Cell and Gene Therapy and Synthetic Gene Production?

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Is your Single-Use Solution Ready for Cell and Gene Therapy and Synthetic Gene Production?

The growth of the biomanufacturing industry has created a demand for new and high-performance fluid handling systems and technologies for the management and storage of cell and gene therapy intermediates and gene-based medicines. New modalities come with risks that don’t yet have good solutions.

One of the biggest risks is contamination. Samples of synthetic DNA can be contaminated with DNA or RNA fragments or worse yet, RNase and DNase from the lab, the environment, the operator, or from single-use components. Even tiny amounts of contamination can be a problem, as they can enter a PCR reaction or enzymatic reagents and amplify during the reaction. This can lead to misleading results, false positives, and even the development of ineffective drugs. Another risk is that synthetic DNA can degrade over time. This can be caused by several factors, including exposure to heat, light, and moisture. Degradation can reduce the effectiveness of synthetic DNA and make it less likely to achieve its intended therapeutic effect.

This is best demonstrated in a recent study and webinar utilizing our Aramus™ Bag versus a traditional polyethylene bag. Aramus™ extremely robust material with lower particle profile vs polyethylene, with a low extractable and leachable profile delivered a human DNA free, DNase free, and RNase free profile in comparison to its (multilayered) polyethylene counterpart-which left traces of contamination. We used sensitive molecular markers and detection assays to monitor contamination level to ensure Aramus is the optimized container in synthetic biology applications and cell and gene therapy workflows. Not only have these bags been validated for use in the storage of synthetic DNA, but their toughness is shown to be effective at preventing contamination and degradation, even under extreme conditions.

It’s important to note that not all solutions are equal, in fact traditional bags constructed of materials such as EVA, FEP, and ULDPE performed worse than Aramus™ bags in benchmark studies in terms of subvisible particulate profiles and aptasensing capability, drastically increasing risk of exposing patients to potential contaminants, and leaving scientists on the hunt to track down what went wrong during stability or other clinical studies. With such time sensitive material coupled with high patient levels, do you have time to balance an exposure or contamination? Even if you have time, would you want to?

While the industry is still on the precipice of synthetic and clinical DNA technology development, the need for safeguards throughout the nucleic acid manufacturing process is critical. Having the best container solution can eliminate myriad contaminants and poor performance and ensure gene drugs safety from early candidates’ discovery and development to late clinical stages. For long-term and low-temperature storage of small amounts of RNA/DNA, it is important to identify a robust and clean polymer surface with ultra-low non-specific adsorption.

Do you know what’s in your bag? Learn more about how to protect your DNA.

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