Process Catalog 2014 - page 79

75
Custom
resins
Resin optimization (semi-custom commercial
resins)
In many cases the optimization of an already commercial
resin can be accomplished by a more judicious selection
of particle size, pore size, and currently available ligands
(Table I). See the various combinations of these physical
parameters in the Toyopearl SEC section of this catalog.
When these products are combined with the comparable
polymer chemistry TSKgel PW products (Table II) , there
are 49 different combinations (Table III) to act as a scaffold
for an improved resin product. All kinds of modes can be
optimized.
Custom resins
In more difficult situations custom resins can be developed
for a customer. Ligand screening, selection, density,
length of spacer arm, degree of crosslinking and degree of
grafting all add to the fundamental scaffold of the semi-
custom resins. The objective in designing a certain resin
is to develop a bead that has maximum accessible surface
area with an optimized ligand density using an appropriate
spacer arm which fits the conformational attachment
requirements of the target. These parameters can have
a dramatic effect on the resin’s chromatographic and
economic performance.
Getting started
To initiate the TRIP program contact your local Business
Development Manager. A period of due diligence will
be started where the appropriate information can be
exchanged in confidence between us. Detailed commu-
nications on these topics requires an in effect two way
Confidential Information Disclosure Agreement between
Tosoh Bioscience GmbH and the customer. If the project
looks promising to both parties several laboratory scouting
samples will be prepared and sent to the customer site for
evaluation.
Commercialization
Once a “Go” decision is made, the performance specifica-
tions are determined from the optimized scouting samples,
the custom resin enters into Tosoh’s “ISO 9001” product
commercialization process. Several small manufacturing
batches are then made to set lot release criteria. Regulatory
support studies are initiated at this time.
Custom
designed resins
1...,69,70,71,72,73,74,75,76,77,78 80,81,82