How to improve analytical method transfers for biotherapeutics

By May 21, 2018


For consistent bioseparations when measuring critical quality attributes, turn to the ACQUITY Arc Bio System

“If it ain’t broke, don’t fix it.”

Then why would any sane laboratory manager choose to improve a validated liquid chromatography method? Or choose to transfer a method from one LC instrument platform to another and expect to get the same results? Isn’t that the definition of madness?

Not if you ask Eric Grumbach, Director of Product Marketing for Chromatography Systems at Waters.

“Assuming continuous improvement is a worthy goal, there is every reason to improve validated chromatographic methods if you’re working with the right instrument technology.”

The instrument technology he’s referring to is a new separations system for HPLC and UHPLC methods, the ACQUITY Arc Bio System.

“The reason that method transfer can induce so much angst, is that for the transfer of an LC method to succeed, the method has to work as well on the new system it is being transferred to, as it did on the original system it was developed on,” says Grumbach ”It’s not a trivial exercise.”

To make things easier, in 2015 Waters introduced its highly-successful ACQUITY Arc UHPLC System. The ACQUITY Arc System was created with a novel selectable dwell volume feature for easily transferring methods from lab-to-lab and from one LC instrument platform to another, within regulatory guidelines and without compromising method integrity. It has since become the workhorse of pharmaceutical development and QC laboratories throughout the world.

In early 2018, scientists got their first look at the new ACQUITY Arc Bio System, a bio-inert, iron-free, quaternary LC system that enables biopharmaceutical scientists to efficiently transfer, develop or improve their bioseparations methods regardless of the LC platform on which they were developed.

 

 

To transfer a method with the ACQUITY Arc Bio System, the analyst chooses one of two flow paths that best replicates the results coming from their legacy HPLC systems.

  • Dwell volume is selectable in the software making it easy to emulate both the dwell volume of the legacy system as well as its mobile phase mixing behavior, and enable the transfer of LC methods from any commercial LC system.
  • And by harnessing the power of Waters Auto-Blend Plus technology, users can program mobile phase composition directly in units of pH and % organic, minimizing human error which can occur when preparing mobile phases manually.

What the ACQUITY Arc Bio System does exceptionally well, is bridge the HPLC and UPLC performance gap while being able to support validated assays. Not only can this novel UHPLC system replicate established HPLC methods as is, but it is also an ideal tool to convert higher performance sub- 2-µm UPLC methods to larger particle HPLC methods for use within the QC laboratory.

Another task it excels at is improving productivity. By leveraging efficient 2.5- to 2.7-µm particle UHPLC columns, like the new BioResolve RP mAb Polyphenyl solid-core Columns, the ACQUITY Arc Bio System gives routine analysis laboratories the means to improve product characterization while increasing the speed of analyses.

With true plug-and-play method compatibility for HPLC and UHPLC bioseparations, hundreds of routine analysis laboratories now have the ability to adopt a modern LC platform that not only improves productivity, but is also a long-term solution to address the issue of transferring legacy methods.

 

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Categories: Pharmaceutical