More than a slogan, bioharmonization is a unifying principle that aims to enhance productivity

By July 23, 2019


In January of 2018, Waters kicked off its global Bioharmonization campaign with a blog post and video release, laying out a vision for how the Biopharmaceutical industry can achieve accelerated development and improved quality while enhancing productivity and lowering production costs.

Central to this vision are “fit-for-purpose” analytical tools working together within a single compliance-ready informatics framework, all backed by expert level service and support to ensure customer success.

As highlighted in additional blog posts throughout 2018, biologic drugs are becoming larger and more complex, and relative to small molecule drugs, greater testing and analysis is required to characterize these molecules, and subsequently develop/validate Chemistry, Manufacturing & Control (CMC) processes. At the same time, competition from “Biosimilars” and increasing pressure from health care providers and governments to lower the costs of biopharmaceutical drugs/therapies are challenging biopharma companies to be much more productive.

In surveying customers about where they see the biggest opportunities to improve productivity, it was clear that data integrity and compliance issues associated with regulatory submissions represent a key challenge for many organizations, as the time delays and added costs that can occur when trying to rectify these issues can be extremely high. Many also see an opportunity to better leverage the multiplexing capability of mass spectrometry to achieve more streamlined analytical workflows that reduce or eliminate the need for a host of conventional assays and techniques. Furthermore, to reduce the risk of failed production runs and/or poor-quality product, companies are increasingly adopting a quality-by-design (QbD) approach to process development, and many are pursuing continuous manufacturing as well – all part of an effort to improve quality, lower costs, and enhance overall productivity.

While achieving our ultimate vision will take many years, good progress has been made, most notably with the launch of our new BioAccord LC-MS System™ for routine biopharmaceutical analysis earlier this year. This first-of-its-kind Smart-MS™ enabled LC-MS solution is a modern fit-for-purpose tool that enables non-MS experts to capture high quality accurate mass data on their biologic molecules throughout development, manufacturing and QC. With automated calibration and self-diagnostic capabilities, it has been shown to generate highly reproducible results from run-to-run, and across instruments. And running under UNIFI – our modern compliance-ready LC-MS informatics platform, it fully supports data integrity and audit trail requirements, and enables customized reporting to streamline regulatory submissions.

With the BioAccord LC-MS solution we have advanced both our portfolio of fit-for-purpose tools as well as our compliance-ready informatics. In addition, we are directly addressing all the key areas for productivity enhancement mentioned above: lowering the risks and costs associated with regulatory submissions; enabling multi-attribute analysis to streamline analytical workflows; and supporting QbD and Continuous Manufacturing through strengthened LC-MS monitoring that can be employed further downstream by non-MS experts.

While much work remains before we can fully realize our bioharmonization vision, the launch of the BioAccord LC-MS solution certainly represents a significant step forward, and the positive response we’ve received from our biopharma customers has only strengthened our resolve to deliver on this promise.

If you would like to learn more about our BioAccord LC-MS solution, please visit: www.waters.com/bioaccord

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Categories: Pharmaceutical