🔬 Next-generation sequencing (NGS) offers fast, sensitive virus detection. It’s gaining regulatory support and may become the standard method.
💡 NGS improves safety for products like cell therapies, detecting known and unknown viruses effectively.
📈 Its implementation could enhance efficiency, reduce costs, and align with ethical testing trends in the industry.
Introduction:
The article discusses the advancements in viral detection methods within the biologics industry, emphasizing the limitations of traditional techniques and presenting next-generation sequencing (NGS) as a transformative alternative. Given the critical importance of ensuring viral safety in biologics, especially with the increasing complexity of products, there is a pressing need for more effective detection strategies to mitigate risks associated with viral contamination.
- Biologics are inherently vulnerable to viral contamination due to their reliance on animal or human-derived materials, which underscores the need for effective detection methods.
- Next-generation sequencing (NGS) provides a rapid, sensitive, and broadly applicable method for virus detection, overcoming the limitations of traditional viral testing protocols.
- Many traditional methods have significant drawbacks, such as lengthy processing times and the inability to detect novel or mutated viruses.
- NGS can perform comprehensive virome analyses and identify both known and unknown viral threats, significantly enhancing the safety of biologics, particularly in cell therapies.
- Regulatory support and economic benefits drive the transition towards NGS, paving the way for its potential adoption as a standard practice in viral testing within five years.
Conclusion:
The article concludes that the integration of NGS into viral testing protocols offers significant advancements in the speed, accuracy, and breadth of detection for viral contaminants in biologics. With evolving regulatory landscapes pushing for the adoption of more innovative methods, NGS is likely to become the standard for ensuring viral safety, thereby reducing risks and improving operational efficiencies in the biologics manufacturing process.
