December 2nd 2022
The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.
January 28th 2022
Texcell North America’s new lab facility in Frederick, Md., will expand the CRO’s capabilities in R&D cell culture, viral clearance studies, and viral safety testing.
April 2nd 2021
A series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.
December 2nd 2020
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
November 1st 2018
The second half of this article describes the testing methods used by the authors to demonstrate the applicability of single-use mixing technology for virus inactivation.
The HSV-1 and HVP-2 titers were determined by the inoculation of test solutions into Vero cell cultures and calculated using the Reed M?ench method.
Viral Filtration of Plasma-Derived Human IgG: A Case Study Using Viresolve NFP
November 1st 2004Human plasma provides a rich source of therapeutic medicines, including gamma globulins, coagulation factors, albumin, alpha anti-trypsin, and others. In 2001, sales of immuno gamma-globulin (IgG) were estimated at $2 billion with a production rate of 50 metric tons for the year.1 A number of new therapeutic products have recently been introduced including Gammimune from Bayer, RhoPhylac from ZLB Behring, and Octagam from Octapharma.
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