According to the company, consolidating these key tests optimizes workflow, saves time and labor, minimizes sample handling, and preserves valuable laboratory space. Consolidation also streamlines data collection and reporting, and improves regulatory compliance in every phase of the bioprocess.
One option with the BioProfile Analyzer is an on-line autosampler, which can automatically sample from up to four bioreactors simultaneously as fast as every six minutes and connect to a bioreactor controller system. “An analytical group would have a difficult time taking this many samples manually,” says Harlan Polishook, marketing communications manager at Nova.
Automation improves the consistency of testing, plus adds a level of documentation, accountability, and control that was previously difficult to achieve. “One of the biggest issues today,” says Polishook, is the need for connectivity to channel data into one location and in one format and to eliminate the need for operators to make decisions.”
Like many companies in the bioprocess monitoring marketplace, YSI Life Sciences (www.ysi.com,/a>) entered through the medical testing/monitoring route. YSI commercialized the first glucose analyzer for whole blood in 1975 and participates in this arena with its 2300 STAT Plus™ clinical blood analyzer.
The upgradeable, multiparameter 7100 MBS analyzer from YSI reportedly measures up to six process parameters simultaneously through three sensor modules containing two chemistry sensors each. Users can mix and match chemistries from among glucose, sucrose, lactate, glutamate, glutamine, ethanol, methanol, ammonium, potassium, and galactose. The last one is a recent addition at the request of one particular customer. According to Steve Grant, eastern U.S. manager at YSI, several additional biotech companies have requested the galactose sensor.
Through a partnership with Groton Biosystems (www.grotontech.com), which manufactures an online sampler that runs with the 7100 analyzer, YSI is developing products for process analytic technology (PAT). Together, the 7100-sampler combination will extract and analyze materials from up to 10 bioreactors. Grant sees opportunities for the combination in the emerging biofuels marketplace, as well as in traditional biotech.
When the FDA promulgated its PAT guidance in 2004, it envisioned process analyzers replacing more traditional analytical laboratories and services. That’s still a big part of the PAT push, but thinking has broadened to include some element of feedback and control to garner the most benefit from PAT.
Dionex (www.dionex.com) has been active in online analysis since 1985 and in 1999 introduced a version of its analyzer that operates with Dionex analytical HPLC instruments to support biomanufacturing and other types of chemical analysis. What’s interesting here is that the Dionex DX800 process analyzer detects and quantifies amino acids and carbohydrates directly, without the need for pre- or post-column derivitization. These molecules are difficult to analyze through spectroscopy-based detectors.
“Bioreactors contain thousands of different molecules,” notes Rick Cooley, who manages the Dionex Process Analytics Center of Excellence. “Chromatography offers the ability to resolve them, and focus on single analytes to determine their impact on the product.” The DX800 acquires samples and multiplexes analytical results from up to 21 individual process streams. It also internally and automatically performs sample preparation (dilution, concentration, addition of reagents). “We’re taking operations that would normally be done offline in-lab, and performing them without human intervention,” Cooley adds.