In its latest major product introduction, announced last month, Agilent Technologies has expanded its line of InfinityLab Bio liquid chromatography (LC) systems. With a sample flow path containing biocompatible materials, the Bio LC portfolio addresses issues such as corrosion and leaching arising from protein interactions with traditional flow path materials such as iron. The portfolio is targeted at biopharma customers and R&D and quality control of biotherapeutics as well as newer treatments, such as cell and gene therapies and mRNA vaccines. However, other application areas can also benefit from the additional robustness.

Agilent’s latest InfinityLab Bio LC systems consists of 3 Bio compatible systems as well as 3 workflow solutions based on the systems. The 1260 Infinity II Prime Bio LC (800 bar, quaternary pump) is designed for routine analyses and high method flexibility. The 1290 Infinity II Bio LC—High-Speed Pump (1300 bar, binary pump), which was launched at the end of last year, provides ultra-high performance and analysis of complex samples. The ultra-high performance 1290 Infinity II Bio LC—Flexible Pump system (1300 bar, quaternary pump) provides higher method flexibility. Agilent introduced its first Bio-inert LC, the 1260 Infinity, in 2010.

As Dr. Stefan Schuette, Vice President & General Manager of Agilent’s Liquid Phase Separation Division, explained, “The key reason for the line extension is the different needs of customers across the value chain, and their very specific needs towards flexibility and productivity. With the three new additional Bio LC systems, we will help our customers to find an even more optimal system configuration for their applications and environment.” Biopharma applications include analysis of critical quality attributes (CQAs), including aggregates and charge variants, as well as pharma applications, such as analysis of oligonucleotides or small compounds chelating with metal.

Key differentiators from other bio LC solutions on the market are in line with Agilent’s approach to the LC market’s overarching needs, according to Dr. Schuette. “It is the depth and width of the complete portfolio, but there’s also unique performance characteristics and capabilities based on new technology that differentiate Agilent’s offering for both core systems and specialized workflow solutions, for instance in the area of automated sample preparation,” he noted. “We also offer specifically designed columns, supplies and services and, very importantly, the easy integration into the existing software environment.” He also emphasized the systems’ ease of use. “If users are already familiar with Agilent LCs, they will be able to use the new Bio LCs without any special training, because they are based on the proven, award winning 1260 and 1290 Infinity II systems, and they have the very same set of functionalities and performance specifications.”

In this way, the new system builds upon LC technology Agilent users are familiar with. “The only difference is that, in addition, the Bio LC systems can handle extreme salt and pH conditions while ensuring the integrity of the biomolecules during automated sample preparation, separation and detection within the UHPLC system,” said Dr. Schuette. He added, “All of this makes it very easy for our customers to implement and integrate the new Bio LC systems into their existing lab environments.” This results in a system that is also flexible for applications areas and methods. “Another great thing about the new Bio LC portfolio is that it can really handle a broad range of different bio and also non-bio methods making it the most universal system available,” he noted.

“The broader portfolio of core systems also allows us to offer even more targeted and specialized workflow solutions for various highly integrated and automated approaches…”

The three new workflow solutions—the Bio 2D-LC Solution, Bio Online LC, Bio Method Development—also provide application flexibility. “The broader portfolio of core systems also allows us to offer even more targeted and specialized workflow solutions for various highly integrated and automated approaches, whether it is, for instance, multi-dimensional 2D-LC, method development, multi-attribute methods [MAM] or high-throughput systems,” explained Dr. Schuette.

The Bio Online LC configuration is Agilent’s first LC offering specifically designed for online LC process analyses. “Customers approached Agilent with the need for better tools allowing them to do real-time monitoring of critical process parameters (CPPs) and CQAs for real-time release of their (bio-) pharmaceutical products,” said Dr. Schuette. “Among the critical pain points of our customers in this field there are, for instance, the lack of process information, the optimization of the process with regard to yields and turnaround times, high variability due to manual interaction and increasing regulatory requirements.” He further explained, “There’s also an increasing demand in the industry to move towards continuous manufacturing and process analytical technology (PAT) based on process control.”

The Bio Online LC includes the new Online Sample Manager and Online LC Monitoring software, which according to Dr. Schuette “coordinates process sampling and sample analysis. They feature new and proprietary technologies offering customers new process monitoring capabilities.” Flexibility is once again a theme. “Especially worth mentioning is the fact, that the InfinityLab Online LC Solutions can be configured with more or less any analytical LC system configuration and detector, including mass specs. Even 2D-LC online sampling set-ups are possible,” he commented.

The new Biocompatible 2D LC solution builds upon Agilent’s 2D-LC technology, which has found wide use in biopharma research for more complex and time consuming analyses. “What customers aim to achieve is to integrate and automate their manual, multi-step assays that sometimes takes longer than 24 hours to prep and analyze. Integration and automation result in lower variability, meaning higher data quality, accuracy and precision—and significantly faster turnaround times,” commented Dr. Schuette. “The reduction in total sample preparation and analysis time can easily exceed 80%.”

Dr. Schuette provided an example. “A rather simple example for this is, for instance, the integration and automation of the two CQA methods for Titer and Aggregation analysis, which can be achieved via ProteinA and size exclusion chromatography in one single 2D-LC run, which takes less than 10 minutes.” In conjunction, Agilent has also introduced a kit for such analyses. “Agilent has just released a dedicated ProteinA-SEC kit for such a 2D-LC MAM solution, which will help our customers to get up and running on this one really fast and conveniently.”

The 1260 Infinity II Prime Bio LC and 1290 Infinity II Bio LC–Flexible Pump began shipping this month. The new Bio LC workflow solutions are planned to be available by the end of year.

For more information on the LC market, see Strategic Directions International’s (SDi’s) The 2021 Global Assessment Report: The Analytical and Life Science Instrumentation Industry.”

 

 

 

 

 

 

 

 

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