RT Journal Article
SR Electronic
T1 Twenty plus Years of Data Demonstrating Virus Filtration as an Effective and Robust Step for Large Virus Removal
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 1
OP 8
DO 10.5731/pdajpst.2020.012591
VO 76
IS 1
A1 Stanley, Brad
A1 Holmes, Veronica
A1 Manzari, Richard
A1 Romanowski, Cara
A1 Tessarz, Anja
A1 Ruppach, Horst
A1 Schreffler, John
YR 2022
UL http://journal.pda.org/content/76/1/1.abstract
AB Virus filtration has been demonstrated to be an effective and robust dedicated viral clearance step that is used in biopharmaceutical manufacturing processes. Here we present virus filtration data from a multicompany collaboration with data compiled from WuXi Advanced Therapies’ and Charles River Laboratories’ internal viral clearance databases spanning more than 25 years. The data were sorted by virus removal and type and then further subdivided into murine leukemia virus only, pseudorabies virus only, and reovirus type 3 only categories to allow for analyses of viral clearance results. A total of 2311 virus filtrations were analyzed, composed of 1516 murine leukemia virus, 385 pseudorabies virus, and 410 reovirus type 3 virus filtrations. These data provide clear evidence that will help supplement both internal and industry-wide initiatives focused on using prior knowledge for the creation of modular claims for small virus retentive filters and allow better allocations of resources typically spent on potentially unnecessary studies.