Pharma may be only one of many industries addressed by the Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy, but this years Pittcon, held in a snowy and blustery Chicago last month, provided a feast for any lover of process analytics. Instruments introduced at the show are tackling some of pharmas biggest technical challenges, from analyzing large, complex biomolecules to characterizing raw material quality outside of the lab.
Also emphasizing user friendliness, and permitting parallel processing in the lab are Dionex Corp.s (Sunnyvale, Calif., www1.dionex.com/en-us/lp47713.html) Ultimate Intelligent LC systems, designed to allow users to automate different liquid chromatography (LC) methods on a single system.
Proprietary is Passé, Outsourcings in Favor
Proprietary solutions are also disappearing, and competitors are working on interconnectable solutions. At Pittcon, Waters Corp. (Milford, Mass., www.waters.com) and Shimadzu Scientific Instruments (Columbia, Md.; www.ssi.shimadzu.com) disclosed that they will jointly develop software, based on Waters Empower chromatography software, that will control Shimadzus Prominence liquid chromatography (LC) systems. Waters has similar alliances with Hitachi and Agilent.
Maintenance is also crossing vendor boundaries, as more vendors offer cross-vendor service outsourcing. PerkinElmer, through its OneSource model, provides computerized diagnostic equipment and detailed instrument information specific to the year of instrument manufacture, model and serial number to provide preventative maintenance on all analytical instruments, regardless of manufacturer. The end result is convenience and cost savings, says Wells. Agilent (www.chem.agilent.com ) offers a similar program, and expects demand for such services to grow by 40% per year.
Entering the fray at Pittcon 2007 was Beckman Coulter (www.beckmancoulter.com), which introduced its SiteMAX asset management solutions, a comprehensive instrument maintenance and service program. With the program, Beckman Coulter assumes service ownership and maintenance expense risk for customers laboratory equipment while providing guaranteed cost reductions.
Founders Walk the Floor; Bioanalytics Sweeps Top Awards
One focus at the show was analytics designed to detect subtle changes in complex proteins and other biomolecules. Many of these systems are based on mass spectroscopy.
Shimadzu introduced AXIMA-TOF2 high-performance MALDI TOF-TOF mass spectrometer, and showcased new software for its MS systems, notably a Formula Predictor designed for its LCMS-IT-TOF mass spectrometer, which uses multiple levels of fragmentation, isotope pattern verification, and fragment-ion filtering techniques to accurately determine the correct formula for unknown components; its GCMSsolution 2.5 software, featuring an Automatic Adjustment of Retention Time (AART) function that saves considerable time during analysis preparation.
MS also took first place in Pittcons Editors Award for best product this year. Winning the Gold was Waters Synapt High Definition Mass Spectrometer (HDMS) (for more on this, including access to a video demo and a brief interview with company founder Jim Waters, click here).
Meanwhile, fellow Silver winner Paraytecs ActiPix capillary-based UV absorbance detectors and spectrophotometers use a patented technology to extend the use of UV Vis. The ActiPix D100 combines the self focusing capabilities of fused silica capillaries with the high speed, high spatial reolution of active pixel sensors, similar to the sensors used in cell phones and digital cameras. The instrument uses UV for both quantification and sizing. According to chief science officer David Goodall, this instrument allows scientists to see a complex reaction taking place in real-time, while quantifying the components.
Tied for Bronze were Bruker, for its laptop computer-sized Alpha FT-IR system, as well as Horiba Jobin Yvons Activa-M ICP-MS (inductively coupled plasma mass spectrometer) using charged-couple device technology. ICP-MS is a rapid, sensitive way to determine selements presence within solutions at less than 1 ppb. (For more information, click here.)
Each vendor has stakes in new defining technologies. Ion mobility, for example, has expanded the range of Waters portfolio. For Agilent, enablers have been capillary flow, trace ion detection and improved software for monitoring and diagnostics, explained President Chris Van Ingen. Within the pharmaceutical industry, drug packaging regulations and higher throughput metabolomics are driving demand, said Shanya Kane, vice president and general manager of the companys life sciences business. The company has moved some of its production base to Shanghai.
Research and diagnostics are converging, noted ThermoFisher Scientifics CEO Marijn Dekkers, and there is an emphasis today on doing more analysis outside of the lab, and putting analytics online. The company has been able to improve technologies and lower costs, said Ian Jardine, vice president of global R&D. For example, its current K Alpha x-ray photoelectron spectroscopy solution is two-thirds the cost of the previous system.
ETQ has already been used with the LTQ for key biopharma applications such as mapping posttranslational modification sites, particularly phosphorylation, explained Ken Miller, product marketing manager for Proteomics at Thermo. t has also been shown to allow for a more comprehensive proteomic sample profile than is possible with collision-induced dissociation alone, and it can be used to fragment and analyze large peptide fragments as well as intact proteins. For more on this, watch the webinar on ETD, accessible via https://advion.on.raindance.com/confmgr/view_stored_doc.jsp?docId=91034398541673712044526654961&docType=recording
But MS was not the exclusive focus for innovation. Switzerlands Buchi (www.buchi.com/NIRFlex-N-500.465.0.html) introduced new software for its FT-NIR NIRFlex, with an improved spectral library, and RapiRelease, developed with Mallinckrodt Baker, a fully validated method based on multiple lots of biopharm, organiz and inorganic compounds traceable to compendia lest data. Its new NIR systems offer enhanced analytics, designed to provide the user, not only with spectral data but also information on material composition.
Chromatography was also a focus for innovation. Shimadzu Scientific Instruments introduced its Prominence Ultra-Fast Liquid Chromatograph (UFLC), which promises high-quality analysis at speeds up to 10 times faster than a conventional HPLC system.
Dionex Corp. introduced a number of chromatography innovations. The company has been growing rapidly since it was established as an ion chromatography supplier in 1975. The result of growth and strategic acquisitions, the company now offers HPLC, capillary and nano LC, solvent exraction, automation and online process analysis, as well as packing materials. Since 1999, Dionex Corp. has grown seven-fold, according to the companys CEO, Lukas Braunschweiler, Ph.D., who discussed the companys history and enabling technologies.The company is devoting 8% of its sales to R&D, Braunschweiler said.
He is particularly excited about Reagent Free IC (RFIC) systems with eluent regeneration, in which a set of purification columns is used to recombine and purify regenerated eluent before it is used again. These systems can operate for 4 weeks, nonstop, without consuming eluent, and will be used for simple water analysis. Braunschweiler expects RFIC to drive future growth, along with automated sample preparation, improved software and separation chemistry and consumables.
At Pittcon, the company also introduced two monolithic ion exchange columns, ProSwift SAX- and WCX-15, designed to facilitate fast mass transfer, even for large biomolecules. The columns are available with quarternary amine or carboxylic functional groups, and optimized for protein separations including monoclonal antibodies.
Another breakthrough was Dionexs UltiMate 3000 Intelligent LC (LIC) systems which will allow lab users to automate different lC methods on one system. This technique uses automated smart routines to ensure that an instrument automatically switches from one analytical method to another, even if it involves a different mobile phase and HPLC column. For example, the switching thoroughly purges the autosampler, directing the purge outlet to waste when alternating from one application to another. Intelligent LC knows when to switch between valves and columns for uninterrupted, automated performance with no user involvement. Application switching leaves the original applications untouched and can be achieved with minimal effort, while fully documenting each method and transition for regulatory compliance.
Its Not the Size, Its the Density
Pittcon may be modest compared with programs like BIO, but what it lacks in size it makes up for in the amount of information it packs into its four-day schedule. Among other highlights were new introductions by:
- Mettler-Toledo (Columbus, Ohio, http://us.mt.com/home), which introduced titration and materials characterization products, measurement instruments and microbalances. Of particular interest was the new LiQC (for liquid quality control) system for simultaneous determination of density, refractive index, pH and color. This fully automated system uses a non-destructive test method and provides flexible data acquisition and export. The company also offers a multi-device version of the LiQC, which integrates an automatic bar-code reader to test at least 30 samples at once.
- Aspectrics, whose vice president of marketing Jim Yano, animatedly demonstrated his companys Encoded Photometrics Infrared (EP-IR) Multi-Component Analyzer. In the past seven months, this innovative spectrometer has won a Most Innovative Products of 2006 award from R&D Magazine and achieved Military 202G Method 204D certification for successfully passing the High Frequency Vibration Resistance Test. Yano also proudly pointed out Aspectrics new Chief Technology Officer: Bob Messerschmidt, who designed and developed the first commercial FT-IR microscope in the early 1980s.
- The expansive Siemens (www2.sea.siemens.com) booth had a more subdued buzz, perhaps because of its diverse offerings. However, the company has near-term plans to amplify its message to the drug industry. So far this year, Siemens has both created an IT Services and Solutions group to extend its automation and business solutions portfolio in specific industry sectors (including pharma) and acquired Plano, Texas-based UGS a global provider of product lifecycle management (PLM) software and services further expanding its potential offerings.
Maryanne Steidinger, Siemens director of U.S. marketing for Manufacturing Execution Systems (MES), noted that the companys software and instrumentation offerings span from raw materials testing through process and packaging automation. Our LIMS (laboratory information management system) can be used at-line, on-line and off-line. It can handle test instruments, alarms and data storage, and it may be integrated into the manufacturing plants MES to help the lab meet the same GMPs as the plant, Steidinger said. Weve got an R&D suite set to come out in May that will add the functionality for managing clinical trials. The UGS acquisition gives us production data management capabilities. And were establishing a Center of Competence for pharmaceutical applications in our Spring House, Pa. location.
- At Ametek (Paoli, Pa.; www.ametek.com), the new IPS-4 integrated process spectrophotometer can measure up to eight wavelengths and quantify five measurement components simultaneously. Features include no moving parts, high signal-to-noise ratio, minimized stray light effects, wide linear dynamic range, and a full spectral acquisition (220-1100 nm). According to Randy Hauer, the customizable instrument has a built-in web-based user interface enabling its use independent of a DCS system.
- Jascos (Easton, Md.; www.jasco.com) P-2000 multi-option polarimeter is designed to be a customizable tool. The instrument can be configured with any 2 source lamps, Sodium (Na), Tungsten Iodide (WI) or Mercury (Hg), providing the ability to obtain polarimetry data from UV to NIR wavelengths. An automated validation program is available for cGMP.
- A new valve (VIP Series) by Airgas, Inc. (Radnor, Pa.; www.airgas.com) safeguards the gas stream and process if a lower grade of gas was wrongly connected to the system, a leak has developed, a component has added a contaminant or there is a purity issue. VIP provides a visual indication if leaks have developed or changes color if a contaminant is present. It is a quick indicator that there is a problem with your gas mixture that prevents larger problems from occurring, says Jim Muller, senior vice president, specialty gases.
- Beckman Coulter, Inc. (Fullerton, Calif.; www.beckmancoulter.com) previewed its DelsaNano series particle analyzers. The new instruments perform both zeta potential and particle size analysis on the same sample. The systems are designed to deliver accurate size measurement on particles ranging from 0.6 nm to 7 µm. The DelsaNano is also designed to measure the zeta potential of concentrated material and solid flat surfaces.
- According to Nancy Rochette, communication marketing specialist at ABB (Quebec City, Canada, www.abb.com/product/us/9AAC910019.aspx), simplicity and versatility are the features behind their new spectrometers with Horizon MB software. The MB3000 is the mid-IR version and the MB3600 is the near-IR model. The softwares logical and customizable interface allows you to configure your work environment and select the data format according to your needs.