Cell Line and Clone Selection

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

Overview

Literature

Application Notes

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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

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Product image of the BioAccord LC-MS System

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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

On Demand Webinars

Accelerating upstream process development with direct PQA and media analysis feedback

PQA data is important in biopharma development, but results are often returned weeks after samples are taken. This webinar explores how connecting the Ambr 15® to the BioAccord LC-MS System produces quality data in less than 24 hours, allowing PQA to drive process parameters with precise PQA profiles.

• Discover how to cut PQA analysis turnaround times by connecting the Ambr® 15 and BioAccord systems.
• Learn how more frequent analysis reveals PQA changes over the course of a culture.
• Dig deeper — gain further insight into cell culture processes from spent media analysis.

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Learn more about the Sartorius Ambr® 15 system

Lean more about the Waters BioAccord LC-MS system

Upstream media monitoring using the BioAccord

In this presentation, using the Waters BioAccord ® LC-MS system with the Acquity Premier UPLC to perform LC-MS based nutrient monitoring for spent cell media analysis using both mammalian based microbial based expression systems will be described.

In this joint, one hour presentation, hear from both Waters and Janssen:
• Using the BioAccord LC-MS System to Monitor Cell Culture Media Nutrient Composition to Support Upstream Bioprocess Development
• Semi-Targeted Spent Media LC-MS Assay to Identify Media Components and Metabolites Impacting Cell Viability

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Accelerating Culture Processes via at-line Quality Attribute and Media Analysis

Biopharmaceutical developers need timely access to critical quality attribute and cell culture media data to inform decision-making for efficient upstream processes.

This webinar reviews the benefits of combining Ambr^® 15 and BioAccord^™ LC-MS system to provide faster results of culture media changes during a run, subunit analysis to enhance product understanding, and automation to streamline process development workflows.

What you will learn:
• Discover how to observe and track changes in over 200 media components during cell culture runs.
• Learn how to generate more information-rich CQA data with automated sample preparation.
• Understand how combining the Ambr® 15 and BioAccord™ LC-MS systems cuts CQA data turnaround times.

Watch Now

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