Boosting Biopharma Productivity with Routine LC-MS

By December 1, 2020

As scientific advances continue to carry researchers into new arenas, it is vital that technology evolves in tandem. At Waters, we understand that it is only by leveraging fit-for-purpose technologies that researchers are able to unleash their creativity and make pioneering scientific breakthroughs.

Scientists working within the rapidly growing biopharmaceutical industry are no exception. With the increasing difficulty of developing new blockbuster small molecule drugs, the emphasis on developing novel biopharmaceutical therapies continues to grow. Biopharmaceuticals possess the potential to combine higher efficacy with fewer side effects, and can offer opportunities for increasingly targeted therapies. Consequently, the field has exploded in popularity in recent years. While biopharmaceuticals open up a wide array of exciting new possibilities, the field also faces unique challenges. The production of highly complex biological macromolecule drugs at scale creates a necessity for the implementation of efficient and effective analytical processes as businesses work to gain a competitive advantage without compromising on drug safety.

The Waters BioAccord LC-MS system

As the impact of biopharmaceuticals continues to increase, the industry faces an evolving regulatory landscape. One challenge users experience is the ability to manufacture complex biological macromolecules in a safe and cost-effective way. Consistency in production is of paramount importance to ensure drug safety and efficacy, and robust analytical technologies are greatly needed to enhance researchers’ understanding of biopharmaceuticals and the processes that produce them. Currently, a combination of analytical techniques is utilized to track the wide-ranging product quality attributes (PQAs) and critical quality attributes (CQAs) of biopharmaceuticals to ensure they remain within optimal design limits.

In order to improve efficiency within the industry, there is a strong drive for a consolidated analytical platform that can reliably and rapidly monitor the PQAs of biopharmaceuticals. The benefits this can bring are manifold, from improving understanding and decision making in product and process development to increasing development speed and efficiency, as well as satisfying regulatory expectations in manufacturing and quality organizations. The Waters BioAccord LC-MS system was designed to accomplish precisely these goals. Incorporating the power of smart technology, the liquid chromatography-mass spectrometry (LC-MS) system offers an all-in-one solution for routine users. Leveraging this platform, it is possible for users of all skill levels to reliably track the PQAs of biopharmaceutical drugs through the discovery and development pipeline.

Opening up new possibilities for routine LC-MS use

By merging a powerful and robust separation technique with a highly selective and sensitive detection technology, LC-MS can rapidly measure multiple components and attributes in complex mixtures within a single assay. Its ability to provide a fast and direct measure of quality attributes makes it the ideal choice for PQA monitoring within biopharma, providing reproducible and high-quality data that can accelerate development and reassure regulatory authorities that the drug product achieves all necessary standards.

However, in order to facilitate routine use and improve efficiency, the analytical techniques implemented must be easy to use and accessible for a range of skill levels. That’s why the Waters BioAccord LC-MS System was carefully designed with ease of use at the forefront. Easy calibration across mass ranges and acquisition modes is built into the software as an automated one-click procedure – a significant advance on previous systems. In addition, the BioAccord LC-MS platform is the first SmartMS™-enabled biopharmaceutical solution. Incorporating self-optimization capabilities, users without expert knowledge of MS can proceed with confidence that they are obtaining high quality, robust and reliable data.

A customer-focused approach

We designed the BioAccord system with a strong focus on the needs of the end user. The instrument was rigorously tested during development using customer-relevant methods across thousands of samples and multiple systems to ensure its effectiveness for core applications – including intact mass analysis, peptide mapping and monitoring (MAM, a multi-attribute method) analysis, as well as released glycan analysis.

In addition to the rigorous testing undertaken during development to ensure confidence in data quality and productivity across multiple applications, the instrument also incorporates a built-in health system. Using the latest SmartMS technology, the system self-monitors and communicates to the user if any remedial action is necessary for optimal operation. In these cases, the BioAccord LC-MS system can diagnose issues and walk users step by step through instrument maintenance, offering guided troubleshooting with visual aids.

By maximizing ease of use and giving researchers confidence that the system is operating properly, the power of the BioAccord system can be accessed by labs that do not have a dedicated MS expert in-house. Following installation, our team provides customer application-specific training to streamline workflows, allowing customers to seamlessly progress from sample to report. Building on this customized support, users of the BioAccord system can rapidly start producing fit-for-purpose data at the point of need, wherever they are in within their company and across the world.

Streamlining tomorrow’s life-changing biopharmaceuticals

At Waters, we place the needs of our customers first and foremost. The BioAccord LC-MS system was carefully designed together with SmartMS technology to open LC-MS up to a broader user base within biopharma and answer a growing need for an all-in-one platform that enables rapid, routine analysis. That’s why we combined customer-focused training and support with easy integration and self-monitoring capabilities in the BioAccord system and support network. Through its unique features, the BioAccord system frees users up to devote their time to uncovering new scientific breakthroughs. In the future, we look forward to seeing biopharma researchers empowered with smart technology delivering a new generation of life-changing biopharmaceuticals to the market.

Learn more about Waters BioAccord LC-MS system.