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SUPRAdisc AKS Carbon Impregnated Depth Filter Modules Activated carbon is an inert microporous material derived from raw material such as peat, wood, coconut, lignite or coal. Activated carbon is characterized by millions of pores of molecular dimensions creating a large and highly adsorptive internal surface area up to 2,000 m 2 per gram. Activated carbon is often used for purification and decolorization of pharmaceutical and chemical products and of foodstuffs. The substances responsible for the color are removed by adsorption unlike in bleaching processes, where the substances are converted. As a function of the concentration of the material to be adsorbed, an equilibrium forms between the phases (liquid or gas) and the surface of the activated carbon. A further characteristic feature of activated carbon is the practically non-polar surface resulting in a high affinity to the likewise mostly nonpolar organic molecules. (For further information see “Adsorption”) Advantages of the SUPRAdisc AKS Modules • No separation of activated carbon necessary • Dust-free processes • Quick and easy module change • In-line sterilization • No channel formatting e.g. with activated carbon columns • Enclosed systems in accordance with GMP • Highly reliable due to patented central core adapter system • Very low hold-up volume • Easily scaleable due to modular design Versions SUPRAdisc AKS depth filter modules are available in three versions for different applications: AKS 6 Applications in the pharmaceutical industry as well as biotechnology, blood and chemical industry AKS 5 Applications in the pharmaceutical and biotechnology sector AKS 4 Applications in the API market
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)
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