3
Methods
iFormulate™ process using the
Prometheus NT.48.
iFormulate™ is a platform technology where
four of the most critical formulation variables of
proteins are evaluated in a multivariate fashion
using a highly advanced response-surface
quadratic design. The experimental design
space evaluates the effect of pH, ionic
strength (NaCl concentration), stabilizer
concentration (trehalose), and buffer
concentration in 20 unique formulations and
five replicates. Therefore, in 25 formulations,
all four formulation parameters and any
interaction between them can be investigated
simultaneously. Since all the formulations are
pre-prepared in a 96-well MTP format, protein
is simply added to the formulations and then
evaluated by a high throughput analytical
method. Figure 1 shows the iFormulate™
protocol.
Figure 1. Protocol used in formulation of proteins using iFormulate™ and Prometheus NT.48.