Why delay until late phase clinical manufacturing before testing if your downstream purification process steps provide sufficient viral clearance? Instead, gain actionable insights early in process development. The Cygnus MockV® RVLP Kit provides a BSL-1 compatible stock solution of non-infectious Retrovirus-like Particles (RVLP), derived endogenously from CHO cell culture, as a spiking agent for viral clearance testing. From your own bench, predict retroviral validation outcomes, incorporate viral clearance into process development/optimization experiments and employ viral clearance to QbD, DOE and HTS approaches. Instead of relying solely on a CRO-provided model retrovirus (XMuLV), you can now independently spike and assess the removal of the original retrovirus-like particle of regulatory concern1.
The MockV® RVLP Kit includes a vial of RVLP stock solution, a 96-well plate for sample analysis, RNA extraction and qPCR reagents, and a well-controlled RNA standard for accurate and reliable RVLP quantification. By following the kit’s easy -to-use protocol, scientists can detect as little as 1 x 103 RVLP/mL, enabling an LRV of ~ 5.0 to be determined. Each kit contains 2.0 mL of RVLP Stock Solution at a concentration of 1 x 1010 RVLP/mL, sufficient for spiking up to 200 mL’s of load material to 1% (v/v), and quantification components for conducting analysis on 23 samples in triplicate. In less than one day, the assay and data analysis can be performed. A real-time qPCR instrument is required along with standard laboratory equipment. Minimal experience with RNA extraction or qPCR protocols is required. Compatible purification steps include Protein A chromatography, virus filtration, anion and cation exchange chromatography, mixed-mode, hydrophic-interaction and size- exclusion chromatography. The MockV® RVLP Kit achieves LRV accuracy to within ± 0.5 for these modes of separation as compared to traditional viral clearance studies with XMuLV model virus
Now, through the use of Cygnus’s BSL-1 compatible viral clearance kits, you can easily and economically quantify viral clearance for downstream process steps in your own lab, on your own timeline.
MockV® RVLP Kit Highlights:
- Gain control over viral clearance -conduct the studies you want to run, when you want to run them.
- Learn about your process - challenge your process steps early in downstream purification development, optimize chromatography steps, test new purification products, employ viral clearance to QbD, DOE and HTS approaches
- Eliminate surprises -confirm that your downstream purification process steps provide sufficient viral clearance prior to validation studies.
- Non-infectious, BSL-1 compatible materials.
MockV® RVLP Kit Features:
- Accurate: XMuLV LRV comparability to within ± 0.5 for many modes of separation
- Provides RVLP spiking stock solution which is the original retrovirus-like particle of regulatory concern1
- Kit provides sufficient materials for 1% spike into 200 mL’s and analysis of 23 samples.
- Portions of kit sold separately to enable flexible approach (see M231-1, M100 and M105).
- Straightforward and detailed assay protocol: pretreat sample, extract RNA, quantify RNA through qPCR.
- Supported by a dedicated technical and tech transfer team.