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The "other" liquid chromatography.

As a key separation tool for laboratory research involving chemical compounds, liquid chromatography has been one of the most well known analytical techniques for over three decades. But the widespread usage of LC goes beyond the research stage. Liquid chromatography is also a powerful technique for the separation and purification of biomolecules in process development and manufacturing. Fueled by the demands of drug manufacturing and the growth of the biopharmaceutical industry, the non-analytical LC market, especially the process LC market, is expected to continue its double-digit growth into the near future. In 2001, the total market for non-analytical LC was over $1 billion. As recent events show, many companies, in both the analytical instrument market and outside of it, are positioning themselves for a larger role in this market.

Non-analytical LC includes preparative and process-scale chromatography. Preparative LC is used in the separation and purification of small amounts of substances for laboratory applications and clinical trials. Primary prep LC techniques include prep HPLC, prep LPLC and flash chromatography. Process LC enables the separation of chemical compounds in large volume for pilot or production applications. Process LC techniques fall into three categories: process HPLC, process LPLC and simulated moving bed systems (SMB).

A distinguishing feature of both the prep and process LC markets is the dominance of one company: Amersham Biosciences. The company's systems feature affinity, gel filtration (size exclusion), hydrophobic interaction ion exchange, and reverse phase chromatography. The company holds significant positions in the prep and process LPLC markets through its ATKA, Bioprocess and STREAMLINE product lines.

As a lab-based technique, nearly all larger-sized analytical LC companies participate in the prep LC market in some form or another, including Agilent, Varian and Waters. Analytical HPLC companies Agilent, Shimadzu and Hitachi only sell prep HPLC systems, while Waters sells both HPLC and LPLC prep systems. Bio-Rad also has a strong presence in both markets with media products for hydrophobic, hydropoxyapatite, ion exchange and size exclusion chromatography. Among prep LC techniques, flash chromatography is the least mature and fastest growing technique. Simpler, faster and less expensive than prep HPLC or LPLC, flash chromatography uses air pressure to push a sample through the column. The majority of flash chromatography vendors are relatively specialized and include Biotage, a division of Dyax, Isco and Jones Chromatography, which was recently acquired by Argonaut Technologies (see IBO 2/15/02). Varian has also targeted this market and recently expanded its line of Flash LC consumables with the purchase of ANSYS Technologies (see IBO 1/31/02).

As a whole, process LC promises greater opportunities than prep LC in coming years. Although they are used to purify substances for large-scale production in the food and beverage, petrochemical and small molecular pharmaceuticals industries, most of process LC systems' accelerating sales growth in coming years will come from biopharmaceutical manufacturing applications. As a greater number of biopharmaceutical drugs resulting from biotech and proteomics research go into full production, process LC will face more demand. But due to the current size and expense of process LC systems, few are purchased each year. Thus, the real growth for the market lies in the aftermarket that includes columns and resins. Also, the better margins on aftermarket products generate higher profits.

While some analytical LC companies compete in the process LC market through their consumables products, few participate in the initial systems market due to the differences in products, end-users and applications. The exceptions are Amersham Biosciences and Varian. Varian entered the market with the purchase of R&S Technology's SepTech LC technology in 2000 (see IBO 10/15/00). Another new entrant to the process LC business is Ciphergen, which acquired BioSepra from Invitrogen last year (see IBO 6/30/ 01) and has since launched a Process Proteomics Services business using its ProteinChip technology.

Amersham Biosciences holds a commanding position in the process LC business, and purchased Dan-Process last year to bulk up its process HPLC offerings. However, Amersham Biosciences does not compete in the SMB market. SMB has only recently been adopted and modified for biopurification. An SMB system is a continuous throughput system of small columns rotated on a carousel, enabling higher and more efficient separations for large volumes. SMB companies include NovaSep, which also makes prep LC systems, Calgon Carbon, and Universal Pharma Technologies (UPT), formed by UOP and Pharm-Eco. Although many SMB companies are more oriented toward industrial applications of the technology, several have begun to target the biopharmaceutical market. UPT and NovaSep provide contract services and UPT is developing a bench-top SMB system.

Millipore is another company closely associated with the process LC market, which it entered with its 1996 acquisition of Amicon from W.R. Grace. It offers LC media and columns for reversed phase, ion exchange, hydrophobic interaction, gel filtration, and affinity separations and K-Prime 40 Biochromatography systems for process LC. Other competitors in the process LC media and column markets include Tosoh Biosep, Merck and W.R. Grace. Last year, Grace acquired the Vydac brand of HPLC columns when it purchased The Separations Group (see IBO 3/15/01). The column and media markets consist of a number of subsegments based on media material, such as resin type, and the technique, such as HPLC and LPLC.

With the opportunities for process and prep LC forecasted to expand due to the biopharma industry and improvements in systems and consumables, more announcements surrounding this market and the companies in it can be expected. However, process-scale LC still faces some resistance from industries, in particular, fine chemical and pharmaceutical manufacturers, which are accustomed to other process separation techniques, such as distillation, recrystallization and extraction. As the potential cost savings and efficiencies of process LC become more widely known, this is expected to change. SMB has been shown to reduce solvent and media costs for chiral separations and can allow optically pure production of drugs that are already on the market.

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Title Annotation:non-analytical liquid chromatography
Comment:The "other" liquid chromatography.(non-analytical liquid chromatography)
Publication:Instrument Business Outlook
Article Type:Brief Article
Geographic Code:1USA
Date:Feb 28, 2002
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