Waters BioAccord LC-MS System With Ambr 15

Source: Waters Corporation
Waters BioAccord LC-MS System With Ambr 15

Take control: Make Decisions Faster With Your Own Quality Data

Upstream Bioprocess Development engineers require a more effective and data driven optimization of cell lines and manufacturing process, aiming at maximizing drug product quality and yield. Informed decision making is often hindered due to lags up to 6 weeks to access Product Quality Attributes (PQAs) or culture media information. The number of samples that can be analyzed is consequently limited.

We believe these results should be readily accessible from the hands of process engineers. Waters has joined forces with Sartorius, to uniquely deliver direct measurement of PQAs and cell culture media characteristics during clone selection and bioprocess development.

The Sartorius Ambr® 15 multiple parallel reactors systems can now benefit from dedicated workflows and connectivity to the Waters BioAccord LC-MS System. This results in maximized drug substance quality and yields, minimized downstream impurities, and accelerated development – saving time and multiple $50K optimization cycles.

  • Correlate Process Intput and Product Quality Outputs: Monitor cell culture media characteristics and product attributes on a single platform
  • Continuous Product Quality Feedback: Access leading indicators to make decisions in near-real time
  • Rely on the BioAccord LC-MS System: A high throughput, easy to deploy and to operate platform for non-expert users with seamless workflows for bioprocess assays

At-Line Information Retrieval Enables New Development Models

Overcome limitations of sequential culture run and testing. Get access to direct measurement of PQAs during clone selection and bioprocess development to allow access to analytical information at point of decision.

  • More analytical data collected for robust statistical analysis
  • Faster turnaround times
  • Instant feedback on quality

Automated Product Quality Attribute Monitoring

A fast end-to-end method for glycoform distribution (intact mass analysis) and purity assessment (low molecular weight analysis).

  • Efficiency: 6 min run time, automated processing and interpretation
  • Multi-attribute tracking: titer, identity, purity, glycan profile, modifications
  • Accessibility: Automated workflows with a system that is easy to deploy and to operate
  • Connectivity: Results feedback to Sartorius Ambr® allowing decision making

Cell Culture Media Analysis

A fast and complete method allowing the screening of 200+ media components in 20min per sample.

  • Efficiency: No additional sample preparation needed
  • Specificity: Compound tracking with high accuracy
  • Information rich: Automated structural elucidation of detected unknown components
  • Reproducibility and sensitivity: Down to sub ng/mL