74
Custom
resins
Overview
Occasionally special purifcation needs require special
adaptions to existing chromatographic resins for optimized
operation of your process. This section explains in general
terms Tosoh’s custom resin development procedure.
Tosoh’s Resin Innovation Program (TRIP)
Tosoh Corporation of Japan has introduced a new resin
innovation program. Ideal candidates for this program
are drug targets that have been selected for clinical trials
which, if successful in the clinic, will be commercially
manufactured. This program is not available for early stage
laboratory research or the isolation of small amounts of
new therapeutic proteins.
New project approval for TRIP
To receive a “Go” status for TRIP some evaluation is needed.
During preliminary discussions, prior to the generation of
scouting samples, an assessment is made of whether the
project fits into Tosoh’s scaffolding capabilities. If a fit is
established, the projected liter volume for the new resin is
reviewed. Decisions are based on the quantity projected
for use after therapeutic approval and launch, but for high
value added resins, projected commercial liter volumes of
less than 100 liters have been approved.
New resin development time line
Tosoh Bioscience and Tosoh Corporation of Japan have the
resources to develop custom resin products. The custom
resin optimization timeline closely mirrors a customer’s
need to produce products for clinical trials. Only with
detailed sample evaluation data from the customer,
chemistry optimization and manufacturing lot release
criteria can be established by Tosoh so a close cooperation
between the customer and Tosoh is crucial.
Table 3
Available particle and pore size combinations
Particle Size
(microns)
200 100 75 65 35 30 20 15
Pore
Diameter
(nm)
>170
>120
100
75
40-50
12.5
5
commercial
experimental
not requested
7 x 8 = 56 possible combinations
available p rticle and pore siz combinations
Custom
designed resins
Traditional Chromatographic Ligands
Table 1
Anion Exchangers
Diethylaminoethyl (DEAE)
Quaternary Anion Exchanger (QAE)
Cation Exchangers
Sulfopropyl (SP)
Carboxymethyl (CM)
Sulfonic Acid (S)
Hydrophobic Interaction
Hexyl
Butyl
Phenyl
Polypropylene glycol (PPG)
Ether
Table 2
Tosoh Methacrylic Base Beads used for SEC
Pore size (nm) 5 12.5 40-50 75 100 >100 >170
Product name
TOYOPEARL 40 50
55 60 65
75 80
HW-Type
TSKgel
G1000 G2000 G4000 G5000
G6000
PW-Type
