1050.1 DESIGN, EVALUATION, AND CHARACTERIZATION OF VIRAL CLEARANCE PROCEDURES
1050.1 DESIGN, EVALUATION, AND CHARACTERIZATION OF VIRAL CLEARANCE PROCEDURES
The virus stocks used in viral clearance studies are critical reagents. Each virus stock should have a traceable, certified source
with full documentation of the controlled production procedures. Virus stocks should meet predetermined criteria for identity,
purity (e.g., sterility, mycoplasma, and adventitious virus testing), infectious titer, stability at freezing temperatures, and minimal
viral aggregates. Analysts should minimize the number of passages from the master or working viral bank in order to reduce
the chance of mutation. Purity of virus preparations should be taken into account in cases when virus preparation impurities
may influence the performance of a certain unit operation (e.g., virus filtration).
