Enhancing Ongoing Tests for Remaining Cellular Contamination in Products
In the world of biotherapeutics, the production process is a delicate balance, and identifying, monitoring, and eliminating host cell proteins (HCP) and host cell DNA (hcDNA) is crucial. Revvity, a leading provider in the field, has announced a suite of Research Use Only (RUO) platforms designed to address these challenges.
Anis Khimani, PhD, Senior Strategy Leader, Life Sciences at Revvity, explains the significance of these new offerings. "Large molecule biotherapeutics are produced in mammalian host cells and purified from complex mixtures," he says. "Chromatin (genomic DNA and histone proteins) interferes with purification steps, binding to protein A resin and eluting with the therapeutic product, impacting yield. Similar challenges are encountered in the removal of hcDNA."
To tackle these issues, Revvity has developed the HostDetect DNA assays. These assays include a built-in internal control for monitoring sample preparation, PCR inhibition, reagent performance, and instrument function. The assay setup allows for flexibility in sample input volume and scalability up to 192 reactions per kit, making it an ideal solution for various production scales.
The HostDetect DNA assays offer independent genome DNA detection for CHO, HEK293, and E.coli host cell types, providing a broad spectrum of coverage for different production methods. Moreover, these assays allow for in-process monitoring on real-time PCR thermal cyclers, offering speed and throughput for in-process monitoring.
In addition to the HostDetect DNA assays, Revvity has also introduced the AlphaLISA and HTRF protein assays. These assays provide low levels of detection, speed, and throughput for in-process monitoring. They offer a broad spectrum of antibody assays to detect between 96% - 99.8% coverage of HCPs, making them a valuable tool in the quest for effective HCP elimination.
The AlphaLISA and HTRF protein assays deliver results in less than 3 hours and are tailored to specific host cell types. They are also well-suited for automation and enable precise and robust real-time monitoring of HCPs. For the detection and monitoring of HCPs, Revvity offers no-wash immunoassay kits based on bead and TR-FRET technologies.
In a market where relevant search results are scarce, Revvity stands out as a provider offering an RUO platform for the detection and monitoring of hcDNA and HCPs in various vertebrate cell types used for therapeutic protein, antibody production, or cell and gene transfer therapy. With these innovative solutions, Revvity is poised to revolutionise the biotherapeutics production process.
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