The latest automation technologies are designed to improve the integration of laboratory equipment - increasing speed of analyses at the same time as reducing running costs. Sean Ottewell reports.
AB Sciex, a global leader in analytical technology, has announced the availability of new software and service offerings to simplify and accelerate the integration of its micro LC technology into regulated bioanalytical laboratories.
The addition of a new software module supporting 21CFR Part 11 and a new IQ/OQ/PQ service to the Eksigent line of liquid chromatography solutions gives pharmaceutical companies, contract research organisations (CROs) and other high-throughput laboratories the opportunity to use a validated approach to micro LC for increasing sensitivity and speed while reducing the cost of running a laboratory.
Regulated bioanalytical labs have been looking for ways to improve productivity and efficiency for their absorption, distribution, metabolism, and excretion (ADME) and bioanalysis assays but haven't been able to take advantage of micro LC because of the lack of tools and precedence to integrate it into an existing lab that follows good laboratory practice (GLP) regulations. The new 21CFR Part 11 module and the new service to qualify the LC system for GLP solve this dilemma for regulated labs by eliminating any doubt that a micro LC solution can be configured to meet required rules and regulations.
For researchers looking for improved sensitivity, efficiency and cost savings, micro LC technology such as the Eksigent ekspert microLC 200 UHPLC system delivers up to a four-fold increase in sensitivity and as much as a three-fold increase in throughput while minimising sample injection volumes. It also can reduce solvent consumption and costs by up to 95 per cent.
Among the regulated labs that are using micro LC is Alturas Analytics, a CRO that provides LC/MS-based services to the pharmaceutical and biotech industries. Scientists at Alturas are using an Eksigent micro LC solution along with AB SCIEX QTRAP technology for an integrated quantitative/qualitative approach.
"By improving the limits of detection with micro LC technology, regulated labs can improve results in bioanalysis," said Shane Needham, lab director with Alturas Analytics. "The availability of the 21CFR Part 11 software module is significant because now we can use micro LC for assays that require regulatory compliance, which gives CROs like us a competitive advantage."
AB SCIEX's industry-leading Ekisgent-branded micro LC solutions complement its line of analytical flow LC and nano LC solutions. The company expanded its chromatography product portfolio in 2012, delivering simplified UHPLC-MS solutions that are tailor-made for a variety of applications. [Page Break]
Configurable LIMS
Autoscribe's Matrix Gemini LIMS is a configurable LIMS solution that requires no coding to create a system that matches users' specific requirements. Its easy-to-use configuration tools allowing users to define screen and menu designs, customer specific tables/modules, multiple screens for the same function - for example different log-in screens for different product classes such as raw materials and finished products - multiple sample numbering systems, and much more.
The configuration tools are used to configure screens and menus that are deployed in both the client/server and browser interfaces. Autoscribe calls this 'one-time configuration' as the changes are made once and are implemented in the desktop and browser clients immediately.
The flexibility of Matrix Gemini LIMS means that it can be used in a wide variety of laboratories, both in size and application. Installations include systems with over 500 concurrent users and single-user, single-PC systems. Matrix Gemini LIMS is therefore suitable for both global organisations and small individual laboratories. Matrix Gemini includes extensive features to assist with the requirements of highly regulated laboratories including audit trails, time and date stamping of all actions, version control of all reference data such as test definitions and extensive features to help with 21CFR Part 11 compliance - such as data entry authentication and comprehensive password management capability. The system may be used with either Oracle or Microsoft SQL Server databases.
Matrix Gemini includes several novel features which simplify its operation. The novel user interface can graphically represent the progress of a sample through the laboratory. Users simply click on a selected step in the workflow diagram and go straight to that LIMS function.
This interface is more intuitive than conventional LIMS menus and better represents the sequence of work in the laboratory, says the company. Moreover multiple workflow interfaces can be used and they can be individually configured to suit different work practices within the laboratory using the standard configuration tools supplied with the software. [Page Break]
A web-based solution
At the annual Pittcon event in March, ATL and iCD teamed up to exhibit their data automation and laboratory information management system solutions.
ATL unveiled its new Sample Master iLIMS - a 100 per cent web-based version of its Sample Master LIMS, built on the.NET framework. Sample Master iLIMS boasts a brand new look and feel - perfect for those organisations with multiple locations or global operations and an interest in utilising tablet technology. ATL says the software leverages the modularity and user friendliness for which Sample Master has become known, with additional new features and integration with the latest version of Result Point.
The company also used Pittcon to launch its TITAN laboratory enterprise resource planning (ERP) system. TITAN leverages nearly two decades of laboratory informatics expertise to define the new standard, offering a feature-rich user experience and increased productivity through streamlined work processes, says ATL. TITAN is highly configurable and provides users the ability to tailor LIMS business rules to match their organisations' requirements.
For its part, iCD exhibited solutions including LABS/Q, a market-leading LIMS for the pharmaceutical and process manufacturing industries, and LABS/QM for SAP integration along with instrument integration via LABS/QM. iCD also exhibited VALIDAT, which it says is the premier method validation software used by top pharmaceutical firms worldwide. The software provides statistical analysis, automatically generates regulatory reports and graphics with full regulatory compliance, and walks users through various checkpoints including precision, accuracy and linearity.
Seamless integration
In March Thermo Fisher Scientific introduced Unity SmartCapture Asset Utilisation Monitoring, a combination of innovative software technology and Unity Lab Services' extensive service expertise.
SmartCapture provides automated daily capture of detailed utilisation information for all instruments in a lab, regardless of manufacturer, technique and control software (Fig. 1). It integrates seamlessly into most existing laboratory computing environments, and protects investments in software, instruments and training (Fig. 2).
Unity SmartCapture Asset Utilisation Monitoring delivers significant benefits, including the ability to reduce unnecessary capital expenditures and laboratory downtime. This solution allows laboratories to match actual instrument usage to optimise service levels and adjust the schedule of planned services such as preventative maintenance and operational qualification. In addition, the data can be leveraged to balance workloads and reduce downtime risk for nearly every instrument in the laboratory.
Meanwhile Hamilton Robotics' new Microlab AutoLys STAR workstation automates sample lysis and DNA extraction. This innovative instrument improves bottlenecks for forensic scientists and other molecular biologists isolating nucleic acids from samples.
The workstation has been tested with blood, saliva, and other types of forensic specimens. It includes specialised equipment including a 2D barcode reader, Hamilton heater-shakers, new AutoLys tubes, four robotic channels to manipulate and transport AutoLys tubes, and a centrifuge.
Key to the new system is Hamilton's proprietary AutoLys tubes that can process up to 600 litres of sample lysate. According to the company, customers have verified the Microlab AutoLys STAR system and found the extracted DNA to be comparable in quality and yield to established methods.
The instrument can also run overnight, thus increasing laboratory productivity. The Microlab AutoLys STAR system improves lab throughput by automating a labour-intensive and slow processes, and eliminates a potential traceability gap in the workflow. [Page Break]
Bio-Rad and Inpeco reach developmenta deal
Bio-Rad Laboratories, a multinational manufacturer and distributor of life science research and clinical diagnostic products, and Inpeco, a leading company in the field of laboratory automation, have entered into a development agreement.
As a result, the two will build interfaces between Bio-Rad's clinical diagnostics platforms for diabetes, autoimmune disease, and infectious disease testing and Inpeco's FlexLab 3.6 system.
Connecting Bio-Rad instruments to the Inpeco FlexLab 3.6 will offer clinical diagnostics laboratories a complete and integrated solution that automates sample processing, consolidates testing platforms, and improves operating efficiency of instruments.
With increasing test volumes and the demand for faster turnaround times, many laboratories are implementing total laboratory automation solutions. Automated track systems prepare, sort, and transport patient samples between instruments, eliminating the need for manual intervention.
The first Bio-Rad systems to be interfaced to the FlexLab 3.6 are the VARIANT II TURBO haemoglobin testing system and the BioPlex 2200 system.
The VARIANT II TURBO system is a fully-automated system that uses high-performance liquid chromatography (HPLC) to deliver fast and precise measurement of haemoglobin A1C, which is then used to monitor average blood glucose levels over time in patients with diabetes.
The BioPlex 2200 system uses proprietary multiplex chemistry to deliver full automation and random access testing for autoimmune diseases and infectious diseases.
"We are pleased to work with Inpeco to connect two of Bio-Rad's highly successful diagnostics testing systems to the Inpeco FlexLab 3.6 automated track system," said John Goetz, Bio-Rad executive vice president and clinical diagnostics group president. "By working with Inpeco, we can provide our customers the benefits of our VARIANT II TURBO and BioPlex 2200 systems along with the workflow efficiencies of total laboratory automation."
