MockV® RVLP Kits

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.