Mixers for viral inactivation
The 50L and 100L HyPerforma Single-Use Mixer (SUM-50 and SUM-100, Life
Technology Corporation, Logan, UT) and 200L XDUO-T Quad Mixing System
(XDM-200, Xcellerex, Inc., Marlborough, MA) were used in the VI
operation for pilot scale IgG4-N1 production in different facilities.
The dimension and geometry of the mixers are presented in Table I. The
drawings of a mixer are shown in Figure 1 using SUM-100 as an example.
For the SUM-50 and SUM-100 mixing system, the impeller (power number
1.21) was top mounted and inserted into solution at
15o. For the XDM-200 mixing system, the impeller
(power number 1.7) was located at the bottom of bag. The VI process was
operated in a SUM-100 bag (SH3B10537.01), SUM-50 bag (SH3B10534.01), or
XDM-200 bag (888-0684-C) with mixing at an agitation speed. Acid or base
was added at a designed addition rate through the reagent addition port.
A pH probe was equipped to record online pH values.
The 2L and 20L bioreactors (Applikon, Foster City, CA) were used as
mixers for laboratory experiments. The impellers (power numbers of 1.5
and 0.87, respectively) were top mounted and vertically inserted into
solution in the biorectors. Acid or base was added at a designed
addition rate through the reagent addition port. Vessels were equipped
with pH probes to record online pH values.