Millipore and Gen-Probe have launched the first joint product from their collaboration to create faster, sensitive, more robust tests for detecting contaminants in pharmaceutical and biotech manufacturing processes.
The speed of the test is important as it allows manufacturers to take corrective action earlier in the production process, which both reduces risks later on and improves the quality of the final product.
"For the first time, [scientists] have a viable alternative to culture-based tests that can take several days to generate results," said Martin Madaus, CEO of Millipore.
Called, somewhat predictably, Milliprobe, the system combines Millipore's sample preparation methods with Gen-Probe's nucleic acid technologies in one microbial screening tool. It uses real-time Transcription Mediated Amplification (TMA) technology to detect microbial contamination within hours.
"We are excited about the progress we have made in our collaboration with Gen-Probe and we look forward to developing additional assays using the MilliProbe system over the next few years," added Madaus.
This first assay targets the bacterium Pseudomonas aeruginosa, which can be found in purified water used during drug production.
"We believe there is a bright future for this new generation of rapid, real-time TMA-based screening tools," said Hank Nordhoff, CEO of Gen-Probe.
Meanwhile, WaferGen has completed the development of its SmartChip real-time polymerase chain reaction (PCR) system, as well as cancer gene panel assays to be used with that system.
Both are set to be tested at the University of Pittsburgh Medical School as part of a collaboration. The firm claims that SmartChip is the first whole genome, high throughput gene expression real-time PCR platform and that it combines the high- throughput capability and cost efficiencies of existing microarrays, with the sensitivity and accuracy of real-time PCR and so ought to be both faster and cheaper for gene expression scientists.
It is estimated that the genetic analysis market alone (comprised of gene expression and genotyping analysis) had approximately $2.4bn (€1.63bn) in worldwide revenues in 2006 ($1.74bn for gene expression and $650m for genotyping). Total global revenue for this market is estimated to reach approximately $5.0bn by 2012.
The instrument can conduct 33,750 assays on a single chip, while standard real-time PCR technologies are only able to run 384 assays on a single plate. Additionally, each of the system's wells is designed to work using only 100 nanoliters - a 1,000th of the reagent and sample required by older technologies.
Dr Steven Shapiro and Prof. Jack Myers, head of the Department of Medicine at University of Pittsburgh, and his team of researchers will using the machine to try and identify therapeutically-relevant biomarkers in the areas of chronic obstructive pulmonary disease (COPD) and lung cancer.
While they work, WaferGen will continue to develop additional assays for the SmartChip, including those focused in the area of toxicology. The company is also already developing an enhanced version of the system that will enable users to conduct 100,000 assays on a single chip. This will enable researchers to use one chip to conduct whole genome gene expression in triplicate.
Nucleic acid amplification and labelling specialists, NuGen Technologies, have launched the WT-Ovation Exon Module, a key component of the firm's system for life scientists to investigate small and difficult clinical tissue samples in exon and gene-level expression analysis studies.
Overall, the system can be used for whole transcriptome amplification, ST-cDNA generation, fragmentation, and labelling. Other components include the WT-Ovation Pico or FFPE RNA Amplification Systems, and the FL-Ovation cDNA Biotin Module V2 for fragmentation and labelling of the cDNA targets. The instrument is deisnged to be used with Affymetrix GeneChip Exon and Gene ST Arrays for analysis.
"The Affymetrix GeneChip Exon ST Array platform has made possible two complementary levels of analysis at a whole-genome scale - gene expression and alternative splicing - allowing researchers to investigate gene expression at the level of transcript diversity," said Dr Sue Pandey, NuGen's vice president of commercial operations.
"Until today, sample preparation and access to difficult clinical specimens has been a challenge. The combination of NuGEN sample preparation technology and the GeneChip platform addresses a significant need in clinical research, and opens doors for potential discoveries in disease mechanism and pathology."
Not satisfied with just selling lab equipment, Beckman Coulter has now set up an installation and 'operational qualification' service for its Quanta SC and Quanta SC MPL flow cytometers.
Called Q-Check, the package enables pharmaceutical scientists to document installation, more easily comply with cGMP and GLP regulatory guidelines and check performance on a regular basis.
"Instrument qualification can be very time-consuming and confusing, especially for first-time systems users," said Karen Bezold, director of the Cellular Analysis Business Center for Beckman Coulter.
Instrument validation includes specification qualification (SQ), design qualification (DQ), IQ, OQ and performance qualification (PQ), from product development to ongoing performance verification.
Lab M has been touting its range of microbiological culture media products for the enrichment and isolation of Listeria from food samples. They cover the requirements of US Food and Drug Administration (FDA), ISO 11290 and US Department of Agriculture (USDA) methods.
Its Buffered Listeria Enrichment Broth Plus (BLEB plus) product comes in a complete blend format, omitting the need for additional supplementation, according to the UK firm.
Californian acoustic droplet ejection technology specialists Labcyte has launched the Echo 520 liquid handler for medium sized labs. By that, the firm means its new machine is suitable for labs that need to transfer up to 100,000 solutions per day. The firm claims its products improve data quality by avoiding loss of sample by adsorption onto tips and intermediate plates.
The Echo 520 uses the same acoustic droplet ejection (ADE) technology as other Echo liquid handlers in the range and could enable pharma companies to reduce the volume of their assays while obtaining more reliable data. The 2.5 nL droplets can be used on 96-, 384-, 1536- and 3456-well assay plates.
As the new machine is designed for medium-sized labs and therefore costs less, it was designed to try and bring Labcyte's ADE technology to a wider number of users, said Dr Elaine Heron, the firm's CEO.
"This new product makes the advantages of ADE accessible to the laboratory which could not afford and did not need the high throughput of our 550 and 555 systems. And these laboratories can feel comfortable knowing that if their throughput needs increase, they can upgrade the 520 to higher throughput versions," she said.
Finally for this week, PerkinElmer has released two new radiation-related products. The first is the Wizard2 automated gamma counter. The reengineered system now has a touch screen to replace the old keyboard, an enhanced user interface, built in security options (that support 21 CFR Part 11 compatibility) and a built-in PC (Windows XP) to facilitate data transfer.
It is available in two models: the 2470 model designed for basic research and routine counting applications such as RIA and chromium release studies and has 1, 2, 5 or 10 detectors (each with 550-sample capacity), and 5 and 10 detectors (each with 1,000-sample capacity); and the 2480 model, which has multilabel counting for more sophisticated research applications such as PET (with 1,000- and 270-sample capacity).
The firm has also launched a new family of Tri-Carb liquid scintillation analyzers (LSAs). These can be used for various applications that require use of radioisotope tracers, in industries from homeland security to nuclear power, and biofuels to pharmaceuticals. The new products feature a barcode reader system, which PerkinElmer reckon is an industry first in liquid scintillation analysers.
