USD 2159 AVL - Filtra

AKS 6
General Characteristics
AKS 6 depth filters contain a special porous
carbon in powdered form, which is mainly
responsible for successful adsorption
processes in many liquid phase
applications. Its typical pore size distribution
(ratio of micropores, mesopores and
macropores) and relatively low
hydrophobicity allows easy access for high
molecular weight molecules and additionally
specific adsorption of materials with a
molecular weight between 1 and 100 kDa
(e.g. natural colorants, humic substances,
biopolymers like PKA)*. With AKS 6 depth
filters, protein solutions (e.g. plasma
products like albumin) can be purified by
selective adsorption of PKA, because the
loss of target proteins is very small. The
more non-specific removal capabilities of
other organic impurities such as natural
colorants from protein solutions is
preserved.
The low iron and aluminium content of the
activated carbon in the AKS 6 depth filters
makes it particularly suitable for applications
such as pharmaceutical and biotechnological
processes.
PKA adsorption (%)
90
80
70
60
50
40
30
20
10
0
Competitor
AKS 6
1 2 3 4
Different PKA adsorption conditions
Endotoxin Content
AKS 6 contains < 0.02 EU/mL after 50 L/m 2
flushing with WFI (AKS 6 doesn’t contain
LAL inhibiting or enhancing substances)
Biological Safety
Certificates by NAMSA are available upon
request.
PKA Reduction
During plasma processing different
important pharmaceutical proteins are
isolated and purified under very specific
conditions, to avoid activation of the blood
coagulation system in plasma. The
production conditions have a strong
influence on the activation of the very
complex coagulation sequence. This may
lead to pharmaceutically very potent
metabolic products, responsible for
inflammation and hypotension syndromes
in patients, who are treated with these byproducts.
Figure 1 Figure 2
PKA adsorption (%)
SUPRAdisc AKS
Carbon Impregnated Depth Filter Modules
(Activation of the blood coagulation system
in vivo is essential and mainly responsible
for healing of wounds performed by very
complex biochemical reactions in blood).
Precise control of the entire production
process is therefore essential during plasma
fractionation.
* (PKA (prekallikrein-activator) is one of the central
metabolic products and is an indicator of the quality of
the plasma production process).
Results of PKA Testing
In several investigations the AKS 6 depth
filter shows distinct advantages in the PKA
reduction compared to competitor products.
(see Figure 1). The adsorption curve
(Figure 2) additionally demonstrates a good
performance of the AKS 6 depth filter in PKA
reduction.
Taking the PKA adsorption into account, the
superiority of the AKS 6 depth filter is even
more significant. The advantages compared
to the competition is evident. The PKA
clearance is a very important application
parameter, which combines the potential of
PKA reduction in human albumin solutions
and selectivity of the adsorption process.
100
90
80
70
60
50
40
30
20
10
0
500 1000 1500 2000 2500 3000 3500 4000
PKA amount (IU/m2 Competitor
AKS 6
x 1000)