The Future of Biopharmaceutical Development Just Became Brighter

By February 28, 2019

In late January, I traveled to WCBP (Well Characterized Biological Products), an industry conference that is hosted every year by the CASSS organization. It serves as a forum that brings together biopharmaceutical industry professionals and various regulatory agencies from around the world to review and discuss the current and future state of biopharmaceutical drug development. I was especially excited this year because I knew we were going to debut the recently launched BioAccord™ System. However, before I describe the benefits of the BioAccord System, it is important to understand the unmet needs of the biopharmaceutical industry. (Image: Chris O’Connell (CEO) and Mike Harrington (SVP of Global Markets) unveiling the BioAccord System.)

Attending WCBP reinforced what had become increasingly clear to me, a paradigm shift is currently taking place in the biopharmaceutical development and manufacturing arena. Quality by design (QbD) and continuous manufacturing (CM) approaches driven by Critical Quality Attributes (CQA)-centric control strategies are being broadly embraced by both biopharma industry and regulatory agencies across the world. It’s also clear that high performance LC-MS solutions enable effective CQA monitoring throughout product/process development, manufacturing and even QC Quality Control (QC), and are very much needed to support these initiatives. However, as reflected by animated discussions in several program sessions, workshops and roundtables, a key challenge the industry must contend with is how to practically deploy LC-MS technologies into regulated development and cGMP manufacturing environments.

Besides having higher expectations for data integrity and compliance, as well as for assay robustness and reproducibility, these labs often lack the MS expertise needed to operate and maintain large research grade LC-MS systems.  In addition, the size and cost of deploying research grade LC-MS systems into these environments is not seen as being easily scalable, which is a problem when redundant systems are often required for backup and replicate systems are needed to support operations across multiple geographic locations.

As an analytical solutions provider, Waters launched the aforementioned BioAccord System in response to our industry partners urgent needs in overcoming these deployment challenges. The BioAccord System is a much needed compact, robust, and easy-to-use Biopharm LC-MS Solution that promises to enable routine biopharmaceutical analysis across the drug discovery, development, and manufacturing pipeline.

This purposefully designed small benchtop accurate mass LC-MS system equipped with SmartMS™ technology is:

  • Seen by many of our beta customers as a game changing system that redefines ease-of-use and ease-of-maintenance and addresses the challenges of data reproducibility and scalable deployment.
  • Optimized for robust, repeatable performance when performing routine analysis of proteins, peptides, and released glycans
  • Workflow driven with automated data acquisition, processing and reporting to facilitate faster speed to results
  • Run under UNIFI™ Scientific Information System – our compliance ready LC-MS informatics platform, ensuring confidence in meeting regulatory requirements

So what are our customers discovering about BioAccord? At WCBP Dr. Mellisa Ly, Principal Scientist from Pfizer, gave a great presentation at Waters Technical Seminar, entitled, “Characterization and Monitoring Quality Attributes in Monoclonal Antibodies using a High Resolution, Small Footprint LC-MS System”.

In her presentation, she shared their early access experience and demonstrated that their platform methods that were established on a research grade MS system all worked well on the much smaller BioAccord System and provided highly comparable results for intact/subunit mAbs analysis, peptide mapping/attribute monitoring, and released N-glycan profiling. We were delighted by the data Dr. Ly presented, as it independently demonstrates the performance capabilities of the system and underscores the value it can bring to those engaged in biopharmaceutical development and production.

If you would like to learn more about how the BioAccord System can be integrated into your analytical workflow, please visit our website.

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Categories: Pharmaceutical