🔬 It emphasizes the challenges in detecting host cell proteins and DNA, crucial for product safety.
🧬 Revvity provides new assays for efficient detection, enhancing workflows.
⚡ These assays enable rapid, real-time monitoring, meeting ICH guidelines and ensuring product purity.
💡 Ultimately, they streamline the biotherapeutic production process significantly.
Introduction:
The article discusses the challenges of monitoring and eliminating residual host cell impurities, specifically host cell proteins (HCPs) and host cell DNA (hcDNA), in large molecule biotherapeutics produced from mammalian host cells. It emphasizes the significance of effective detection techniques in ensuring product safety and quality in biopharmaceutical applications.
- Host cell impurities, including HCPs and hcDNA, pose risks such as adverse immune responses and interference with therapeutic efficacy.
- Current analytical methods like ELISA and LC-MS face challenges in monitoring low-abundance HCPs due to insufficient sequence databases.
- Revvity offers specialized platforms, including qPCR-based assays for hcDNA detection tailored for common host cell types, providing high sensitivity and compliance with guidelines.
- The HostDetect DNA assay provides flexible, scalable options for in-process monitoring, ensuring quality through built-in internal controls.
- No-wash immunoassay kits, like AlphaLISA and HTRF, facilitate efficient detection of HCPs, offering rapid results and automation compatibility for streamlined high-throughput workflows.
Conclusion:
The article underlines the critical importance of advancing detection methods for host cell impurities in biotherapeutics. The innovative solutions provided by Revvity not only enhance monitoring capabilities but also improve throughput and automation, crucial for maintaining product quality and compliance in the biopharmaceutical industry.
