Overcoming Problems in Biopharma with Mass Spectrometry

SCIEX have launched their new X500B QTOF Mass Spectrometry System. The new model brings simplicity, high performance and robustness for biotherapeutic analyses. The user-friendly OS software interface and powerful processing software comprise an integrated LC-MS solution for mass spectromatery analysts.The X500R QTOF System emerged in 2015 as the first LC-MS solution designed specifically for routine food, environmental and forensic testing.

To find out more, and to see how the new system helps overcomes current problems in biopharma, we spoke to Farzana Azam, Senior Director of Pharmaceutical Business at SCIEX.

LS: Tell us about the challenges of biologics characterisation for biopharma.

Farzana Azam (FA): There are a number of challenges for biologics, spanning from the need for more comprehensive characterisation and detailed data, to the demanding regulatory requirements for filing, approval and the increased complexity in new molecules. Mass spectrometry is becoming more widely used to address these challenges, as well as others.

LS: Why is mass spectrometry so suited?

FA: Mass spectrometry (MS) is well established as a technique for characterising biopharmaceuticals. MS is widely used for confirmation of the molecule’s primary sequence, post-translational modifications, and in many cases identification and quantification of impurities that may be present. All of this work can be conducted in a very targeted manner due to the specificity that mass spectrometry provides. This specificity, with sensitivity, are key drivers for increased MS use.

LS: What are some of the traditional problems with using mass spectrometry?

FA: Mass spectrometry has historically been quite complex and has required a degree of expertise to both acquire and interpret data. Traditionally, it has been used by mass spectrometrists, but is increasingly becoming a more commonplace analytical tool throughout drug development. This has led to a requirement for simple acquisition and data processing software to aid its use for “non-mass spectrometrists”, giving them the ability to harness the power of MS. This allows “non-mass-spec experts”, such as biologists, to easily acquire and interpret data, enabling faster access to higher quality data to enable critical go/no-go decisions. Simplifying MS will continue to move it out of traditional analytical laboratories and further downstream to support production and commercialisation efforts.

LS: How does your new product overcome these?

FA: The X500B QTOF System has been developed with ease-of-use as the primary driver and with the requirements of non-mass spec experts at the forefront. The X500B solution has the completely redesigned SCIEX OS software platform for instrument control, data acquisition, data processing and reporting functionality. The intuitive and simplified user interface is easy to learn and master for acquisition of characterisation workflows for routine and expert use.

BioPharmaView data processing software assists in automated biotherapeutic data processing, simplifying and accelerating biologics characterisation for comparability at a glance. Additionally the hardware has been completely redesigned and X500B has one of the smallest footprints of any TOF product in the market place. The combined X500B solution was built to address the challenges of biologics characterisation for both non-mass spectrometrists as well as the expert user.

Farzana Azam was speaking to Louise Saul, Editor for Technology Networks.