VIRAL SAFETY, VIRAL CLEARANCE AND VIRAL INACTIVATION TEST

Generally, a viral clearance study, from initial planning to final report issuance, is comprised of the following steps:

 

•Risk assessment of the product regarding viral safety

•Selection of target viruses to  be tested for viral clearance

•Selection of process steps to be evaluated for virus elimination

•Down-scaling the selected manufacturing steps

•Preliminary studies of cellular toxicity and viral interference

•Viral-spiking process runs

•Collection and titration of the process samples

•Data generation and calculation of viral clearance factors

•Issuance of the final reports

Actividad viricida contra el Adenovirus tipo 5, cepa Adenoide 75, (ATCC® VR-5™), medida en A549 (ATCC® CCL-185™). 

Actividad viricida contra el Norovirus murino (MNV-1) (ATCC PTA-5935) medida en RAW 264.7 (ATCC® TIB-71™)

Actividad viricida contra el MVA Vaccinia virus (ATCC® VR-1566™) medida en BHK-21 BHK-21 [C-13] (ATCC® CCL-10™). 

Actividad viricida contra el MVA Vaccinia virus norovirus (ATCC® VR-1566™) medida en SL­29 (ATCC® CRL­1590™)

Actividad viricida contra el parvovirus Rodent protoparvovirus 1 (ATCC® VR­1346™) en A9 (ATCC® CCL­1.4™).