Recently, an international group of plasma fractionators met at the 10th Plasma Product Biotechnology Meeting to discuss the latest developments in plasma-derived therapeutic production including manufacturing, regulatory affairs, and technical process innovations.
The following Merck presentations at the forum focused on Immunoglobulin (IgG), the driver of the plasma industry, the switch to subcutaneous administration and increasing regulatory requirements on isoagglutinin.
Current trends in the bioprocessing industry are driving plasma producers to formulate at higher protein concentrations. As a result, formulating using tangential flow filtration (TFF) may be limited in reaching these concentrations due to high pressures caused by highly viscous feed streams. Filtration devices used during processing must be optimized in order to handle both high viscosity and pressures while maintaining high flux and excellent product recovery.
Watch this webinar for more information about a recent study of filtration devices that can overcome process limitations due to high viscosity formulations.
Trace amount of anti-A and anti-B can lead to serious side effects in patients receiving IgG treatments, and can be lethal in severe cases. Anti-A and anti-B clearance from final IgG products may be even more critical for higher concentrations.
To specifically target the removal of anti-A and anti-B isoagglutinin antibodies from plasma-derived IgG therapeutics, two new affinity resins have been developed. These resins use Merck’s proprietary base matrix to remove trace amount of ABO blood typing antibodies, anti-A and anti-B.
Merck Millipore + Sigma-Aldrich =
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Operating in the U.S. and Canada
To learn more about our purification solutions in plasma-derived therapeutics, visit the Plasma Learning Center.