MockV® RVLP Kits

Evaluating viral clearance of a drug manufacturing process is often delayed until late-phase clinical manufacturing due to prohibitive time and cost. The Cygnus MockV^® RVLP Kit overcomes these issues, allowing you to economically quantify viral clearance for downstream process steps in your own lab, on your own timeline.  

The 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.

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.

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.