Upstream Bioprocessing

Upstream Bioprocessing

Speed up cell line and upstream process development with automated sample-to-result workflow using Waters Bioprocessing Walk-up Solutions. Enable routine monitoring of bioreactions with accelerated LC-MS analysis for protein titer, spent media, and product quality.

Speed up cell line and upstream process development with automated sample-to-result workflow using Waters Bioprocessing Walk-up Solutions. Enable routine monitoring of bioreactions with accelerated LC-MS analysis for protein titer, spent media, and product quality.


Overview

Efficient upstream bioprocessing, from cell line development (CLD) to upstream process development (USP), demands sensitive, robust, and high-throughput analytical platforms. Waters Bioprocessing Walk-up Solutions are ideal options for at-line process analytical technology (PAT) to overcome burdensome routine monitoring of critical process parameters (CPPs) and critical quality attributes (CQAs), with the ability to integrate with bioreactors such as the Sartorius Ambr 15 or Ambr 250.

The automated LC-MS based platform is designed to accelerate upstream bioprocessing with rapid turnaround times by:

  • Streamline the workflow from sample preparation to data acquisition through data processing with samples from bioreactors

  • Guide process development with routine monitoring of protein titer, spent media, and product quality
  • Enable faster, more confident decision-making with direct data connectivity from LC-MS into JMP 

Applications

Cell culture media (CCM) components, such as nutrients and metabolites, can directly impact the CQAs of the final product. Learn how Waters helps process scientists to create the right environment for the optimal growth of cells, enabling effective media optimization, development, and monitoring.

Cell culture media (CCM) components, such as nutrients and metabolites, can directly impact the CQAs of the final product. Learn how Waters helps process scientists to create the right environment for the optimal growth of cells, enabling effective media optimization, development, and monitoring.




Infographic: At-Line PAT Solutions for Upstream Bioprocessing

Waters Bioprocessing Walk-Up Solutions, as an at-line PAT for upstream bioprocessing, enable sample-to-result workflows for monitoring the CPPs and CQAs. Download the infographic for a step-by-step overview of how Waters integrated solutions can help accelerate your bioprocess development.

Waters Bioprocessing Walk-Up Solutions, as an at-line PAT for upstream bioprocessing, enable sample-to-result workflows for monitoring the CPPs and CQAs. Download the infographic for a step-by-step overview of how Waters integrated solutions can help accelerate your bioprocess development.


HPS oligonucleotide preparative columns ensure high recovery, consistent and reliable impurity profiling from the very first injection.

Solutions


Accelerate your upstream bioprocessing development timelines with the Waters Bioprocessing Walk-Up Solutions.

Accelerate your upstream bioprocessing development timelines with the Waters Bioprocessing Walk-Up Solutions.

Automated and routine analyses for CCMs and PQAs

Automated and routine analyses for CCMs and PQAs

The BioAccord System with the Automation Portal is an LC-MS based PAT solution with automated sample-to-result workflows for rapid assessment of both CPPs and CQAs for samples from bioreactors.

  • Cell Culture Media Analysis
  • Product Quality Attributes Monitoring


The data speaks for itself

The data speaks for itself
Representative trend plots of metabolites displaying bioreactor sampling over time. Representative results for Tryptophan (absolute concentrations) and Choline (relative trends) shown. Representative trend plots of metabolites displaying bioreactor sampling over time. Representative results for Tryptophan (absolute concentrations) and Choline (relative trends) shown.
Representative UV and MS TIC chromatogram of media sample post protein A purification. (right) %Glycan determination from protein A purified sample, showing overlaid bar plot of each of the glycan as a function of bioreactor and over time. Representative UV and MS TIC chromatogram of media sample post protein A purification. (right) %Glycan determination from protein A purified sample, showing overlaid bar plot of each of the glycan as a function of bioreactor and over time.
An example of abundance changes An example of abundance changes of choline in spent cell culture media is shown by the trending plot bar chart for 12 different bioreactors across multiple days.
Bar trend plot of raw response from 100 injections. (A) leucine, (b) stable isotope labeled leucine, and (c) response ratio of leucine/SIL-leucine. The plot shows signal variation in raw response is corrected by employing an internal standard. Bar trend plot of raw response from 100 injections. (A) leucine, (b) stable isotope labeled leucine, and (c) response ratio of leucine/SIL-leucine. The plot shows signal variation in raw response is corrected by employing an internal standard.
Shown are the HT SEC separations of NISTmAb. Mobile phase was 1.5X DPBS and injection volumes were 0.8 µL for the 150 mm columns and 0.5 µL for the 100 mm column. Columns and flow rates are: A) 1.7 µm (150 mm) at 0.50 mL/min, B) 2.5 µm (150 mm) at 0.50 mL/min, C) 2.5 µm (150 mm) at 1.00 mL/min, D) 1.7 µm (100 mm) at 0.75 mL/min, E) 1.7 µm (100 mm) at 0.90 mL/min. UV absorbance detection was performed at 20 to 40 Hz. Shown are the HT SEC separations of NISTmAb. Mobile phase was 1.5X DPBS and injection volumes were 0.8 µL for the 150 mm columns and 0.5 µL for the 100 mm column. Columns and flow rates are: A) 1.7 µm (150 mm) at 0.50 mL/min, B) 2.5 µm (150 mm) at 0.50 mL/min, C) 2.5 µm (150 mm) at 1.00 mL/min, D) 1.7 µm (100 mm) at 0.75 mL/min, E) 1.7 µm (100 mm) at 0.90 mL/min. UV absorbance detection was performed at 20 to 40 Hz.
Overlaid extracted ion chromatogram (XIC) of general compound coverage, isobaric pair isoleucine/leucine, and isocritic acid/citric acid  Overlaid extracted ion chromatogram (XIC) of general compound coverage, isobaric pair isoleucine/leucine, and isocritic acid/citric acid 
Comparison of LC-MS separation of the mAb Subunit Standard on a 2.1 x 20 mm BioResolve Premier RP mAb Polyphenyl 450 Å 2.7 µm Column (4-minute gradient) and a 2.1 x 100 mm BioResolve RP mAb Polyphenyl 450 Å 2.7 µm Column (20-minute gradient). Comparison of LC-MS separation of the mAb Subunit Standard on a 2.1 x 20 mm BioResolve Premier RP mAb Polyphenyl 450 Å 2.7 µm Column (4-minute gradient) and a 2.1 x 100 mm BioResolve RP mAb Polyphenyl 450 Å 2.7 µm Column (20-minute gradient).

Webinars and Resources

  • Application Notebook

At-line Solutions for Upstream Bioprocessing Application Notebook

At-line Solutions for Upstream Bioprocessing Application Notebook
  • Brochure

Connected Upstream Bioprocessing

Connected Upstream Bioprocessing
  • Brochure

Bioprocess Walk-Up Solutions

Bioprocess Walk-Up Solutions
  • Blog

Biopharma’s Future: Next-Generation LC-MS Workflows for Peptide MAM

Biopharma’s Future: Next-Generation LC-MS Workflows for Peptide MAM
  • On Demand Webinar

Performing Product Quality Measurements in your Bioprocessing Lab - It's Easier Than You Think

Performing Product Quality Measurements in your Bioprocessing Lab - It's Easier Than You Think
  • On Demand Webinar

Faster Upstream Processes vis Direct CQA and Media Analysis Results

Faster Upstream Processes vis Direct CQA and Media Analysis Results
  • On Demand Webinar

Pushing the Boundaries of Chromatography for Ultra-Fast Bioseparations

Pushing the Boundaries of Chromatography for Ultra-Fast Bioseparations
  • On Demand Webinar

Streamlining Glycan Analysis: From Sample Preparation to Data Analysis

Streamlining Glycan Analysis: From Sample Preparation to Data Analysis
  • User Manuals

Bioprocess Walk-Up Solutions Pre-Installation Checklist

Bioprocess Walk-Up Solutions Pre-Installation Checklist

Related

Accelerate process development and drug discovery and development timelines with Waters online or at-line solutions for upstream and downstream bioprocessing labs.

Learn more about Upstream Bioprocessing Solutions.

Learn more about Upstream Bioprocessing Solutions.

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