Understanding Bioprocess Complexity: Advanced Analytical Profiling and JMP (2025-US-30MP-2597)

The biopharmaceutical industry has generated many valuable products. Yet if the analytical tools used are difficult to operate or don't work in concert, practioners can struggle to understand the complex systems they employ to achieve those Eureka moments.

We demonstrate a real-world example of the powerful combination of routine PAT (process analytical testing) using chemical analytics performed by LC-MS (liquid-chromatography-mass-spectrometry),data analytics, and graphics bundled in intelligent workflows, progressing to understanding and breakthroughs in bioproduction development. By integrating high-end hardware and software, bioprocess engineers can quickly decipher parameters that they control or influence to optimize productivity, yields, and quality.

This presentation represents a three-way collaboration between Waters, CSL Seqirus, and JMP. Waters Corporation's LC-MS BioAccord system measured very detailed profiles in a high throughput bioreactor system during a DOE study. The BioAccord was used to measure product titer and quality attributes of the protein biotherapeutic, as well as feed and metabolic components to enable a rich daily snapshot of the process profiles. These analytics enable users to see the impact of process changes on stress markers, productivity, and quality at an unparallelled level.

The Waters Bioprocess Monitor Add-In, available in the JMP Marketplace, gathers data from the BioAccord platform and makes it available graphically in JMP; it is being used successfully at CSL Seqirus. By applying a series of analyses in JMP, we can understand relationships between parameters and, thus, guide discovery toward maximizing yield, purity, and process reliability of the target substance with a robust, well-characterized process.