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Corporate Capabilities ADVERTORIAL Asahi Kasei Bioprocess Downstream Bioprocessing Industry Leader Backed by Planova™ Virus-Removal Filters TechniPur ideal for ion exchange (IEX), size exclusion (SEC), affinity and immobilized metal affinity (IMAC) chromatography. Improving HPLC and Bioprocess Chromatography Preparative and commercial-scale produc- tion requires instrumentation to accommodate complex separations. Knauer Preparative HPLC Systems feature a modular design that maxi- mizes product yield in a minimal amount of time. Once a particular process enters clinical- scale production, HPLC columns and systems from AKB purify oligonucleotides, peptides, and small-molecule APIs. For separations that re- quire finer resolution, UHPLC columns and sys- tems operate under higher pressures with silicas as small as 5 µm in diameter. A Asahi Kasei Bioprocess 1855 Elmdale Avenue Glenview, IL 60026 Phone United States 800.865.4100 Website www.ak-bio.com Date Founded 2010 Number of Employees 45 sahi Kasei Bioprocess (AKB) provides pharmaceutical and biopharmaceuti- cal manufacturers with a comprehen- sive suite of tools to maximize safety and improve yields of biotherapeutics during pilot, clinical, and commercial-scale production. Virus filtration has been AKB's strength since 1989 when Planova became the world's first virus-removal filter for biological products and plasma derivatives. Other areas of expertise in- clude impurity removal, liquid chromatography, inline buffer dilution, and oligosynthesis. Global headquarters are located in Tokyo, Japan as the Bioprocess Division of Asahi Kasei Medical Co. In Glenview, IL, a 2,300 m2 facility supports equipment manufacturing and R&D.; Asahi Kasei Bioprocess Europe in Belgium and Germany distributes bioprocess products and offers seminars and hands-on training to cus- tomers. Offices in Singapore and China also sup- port AKB's market development. Revolutionizing Virus Filtration with Planova Planova 15N, 20N, 35N, and 75N virus-re- moval filters operate by size exclusion and are available in four nominal pore sizes: 15 nm, 19 nm, 35 nm, and 72 nm, respectively. Viruses become trapped in the interconnected network of void and capillary pores present in hollow- fiber membrane walls. This robust virus-re- moval mechanism allows virus to be retained while maximizing protein yield, as product is not adsorbed. Process scale-up is simplified because Plano- va filters are available in surface area sizes from 0.001 m2 to 4.0 m2 with the same standardized hollow-fiber format. Following Planova filtra- tion, mandatory post-use integrity testing is ex- pedited using the automated Asahi Gold Particle Test System (AGPTS). For filtrations involving high protein concen- trations and higher pressures, Planova BioEX is ideal. Made of polyvinylidene fluoride (PVDF), Planova BioEX combines the reliable perfor- mance and scalability of Planova filters with a simplified and sensitive integrity test. All Pla- nova filters are compatible with the new Virus Filtration Controller (VFC). Since floor space in manufacturing facilities is limited, the VFC pro- vides consistent, automated virus removal in a compact footprint. Overcoming Purification Bottlenecks Other applications of hollow fiber technol- ogy include BioOptimal™ MF-SL, a microfilter for cell culture clarification, and the QyuSpeed™ D anion exchange membrane adsorber. BioOptimal MF-SL combines size exclusion with tangential flow filtration to facilitate rapid processing of large volumes. Cells are gently separated from proteins to minimize cell-de- rived impurities. In contrast, DEA ligands attached to grafted chains allow QyuSpeed D to bind negatively charged impurities regardless of flow rates and with relative insensitivity to salt concentrations. High binding capacity, reusability, and an eco- nomical alternative to column packing represent additional benefits. AKB has also launched the TechniPur™ aga- rose family of chromatography media. Tech- niPur agarose is a highly rigid base matrix op- timized for protein purification. Novel cross- linking technology coupled with the proven re- liability and chemical stability of agarose make 64 | October 1, 2012 | genengnews.com | Genetic Engineering & Biotechnology News Alternatively, Knauer BioLine Biochro- matography columns offer flexible bed heights for medium and high-pressure applications in- volving monoclonal antibodies (mAbs) and pro- teins. Purification processes involving similarly large molecules can be performed using biopro- cess columns and bioprocess chromatography skids manufactured by AKB. Creating On-Demand Buffers To expedite processing of increasingly larger protein-expression titers, IBD™ Inline Buffer Di- lution Systems prepare 1X binary and ternary buffer blends from up to 20X salt solution con- centrates. Process analytical technology (PAT) controls pH and conductivity simultaneously while the small footprint helps replace buffer tanks with disposable bags. When ready, result- ing buffers are delivered to existing downstream processing equipment, such as bioprocessing chromatography systems, to accelerate capture, polishing, virus filtration, and fill/finish of bio- logical products. Synthesizing Therapeutic Oligonucleotides Nearly 250 programs are under devel- opment for therapeutics such as antisense oligos and siRNAs. Furthermore, in 2011, approximately $400 million was invested within this niche. To support such growth, AKB builds axial and static compression synthesis columns for clinical and commercial-scale manufacturing featuring adjustable bed heights and uniform flow distribution. Synthesis columns are paired with oligonucleotide synthesizers to regulate reagent delivery and monitor conductivity, UV, pressure, and density. Q