Upstream Bioprocessing

Upstream Bioprocessing

Speed up cell line and upstream process development with automated sample-to-result workflow using Waters Bioprocessing Walk-up Solutions. Accelerate LC-MS analysis of cell culture media, protein titer, and intact mass, for simultaneous critical process parameter (CPP) and critical quality attribute (CQA) evaluation.

Speed up cell line and upstream process development with automated sample-to-result workflow using Waters Bioprocessing Walk-up Solutions. Accelerate LC-MS analysis of cell culture media, protein titer, and intact mass, for simultaneous critical process parameter (CPP) and critical quality attribute (CQA) evaluation.
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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 CPP and CQA measurements, with the ability to integrate with bioreactors like the Sartorius Ambr 15 or Ambr 250 Bioreactors.

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

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

  • Generating quantitative analytical results (both CPP and CQA) to guide process development

  • Enabling faster, more confident decision-making with high quality data for samples from bioreactors

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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.

Application Notes

Hand in hand with CCM monitoring, in-process monitoring of product quality attributes (PQAs) offers deeper understanding of biopharmaceutical development and manufacturing processes. It is essential for obtaining the highest protein yield with the CQA in check. Learn how Waters Bioprocess Walk-up Solutions enable automated monitoring for both PQAs and CPPs for samples from bioreactors, helping to minimize batch failure, manufacturing delays, and reduce human errors.

Hand in hand with CCM monitoring, in-process monitoring of product quality attributes (PQAs) offers deeper understanding of biopharmaceutical development and manufacturing processes. It is essential for obtaining the highest protein yield with the CQA in check. Learn how Waters Bioprocess Walk-up Solutions enable automated monitoring for both PQAs and CPPs for samples from bioreactors, helping to minimize batch failure, manufacturing delays, and reduce human errors.

Application Notes

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.
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Embryonic stem cells, cellular therapy

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
BioAccord LC-MS System

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

Purposely created to meet the needs of process development labs enabling automated and streamlined workflow, from sample preparation to data acquisition to report generation.

Purposely created to meet the needs of process development labs enabling automated and streamlined workflow, from sample preparation to data acquisition to report generation.

Accelerate upstream bioprocessing with streamlined workflows

Accelerate upstream bioprocessing with streamlined workflows
waters_connect for biopharmaceuticals

Get adaptable sample-to-result workflows with waters_connect for the needs of process development labs. The CCM workflow with dedicated library enables rapid nutrient monitoring and efficient media optimization, and the Intact Mass workflow allows rapid estimation of PQAs like intact mass and glycan profiles.

  • Cell Culture Media Analysis
  • Product Quality Attributes Monitoring

Design and execute laboratory protocols

Design and execute laboratory protocols
OneLab Software

Design and execute every step of your laboratory experiment on your own PC or tablet with OneLab Software, and generate automatic reports to fully support both troubleshooting and auditing requirements.

  • Cell Culture Media Analysis
  • Product Quality Attributes Monitoring

Maximize productivity with minimal human intervention from sample to result

Maximize productivity with minimal human intervention from sample to result
Andrew+ Pipetting Robot

The Andrew+ Pipetting Robot provides a flexible platform solution for preparation of clarified and raw bioreactor samples ahead of analysis, ensuring the highest data quality. OneLab Software orchestrates automated sample preparation, transfer, and LC-MS analysis of bioreactor samples using the Andrew+ Pipetting Robot and BioAccord LC-MS System with Automation Portal. Simply load your sample onto the Andrew+ Pipetting Robot, then review results when analysis is done.

  • Cell Culture Media Analysis
  • Product Quality Attributes Monitoring

Achieve faster chromatography for proteins and glycoproteins

Achieve faster chromatography for proteins and glycoproteins
ACQUITY Premier High Throughput Columns

Achieve faster analysis for proteins and glycoproteins with high throughput ACQUITY Premier Glycoprotein Columns and ACQUITY Premier Protein SEC Columns, and improve your productivity by reducing analysis time and cost-per-sample.

  • Cell Culture Media Analysis
  • Product Quality Attributes Monitoring

Faster chromatography for charge variant analysis and intact/subunit analysis

Faster chromatography for charge variant analysis and intact/subunit analysis
BioResolve Premier Columns

Achieve fast analysis for large biomolecules, like monoclonal antibodies (mAbs), with BioResolve Premier Reversed-Phase mAb Polyphenyl Columns and BioResolve Premier SCX mAb Columns, ideal for charge variant analysis and intact/subunit analysis.

  • Cell Culture Media Analysis
  • Product Quality Attributes Monitoring

Improve retention and sensitivity for cell culture media with purposefully designed columns

Improve retention and sensitivity for cell culture media with purposefully designed columns
ACQUITY Premier HSS T3 Columns

Ideal for enhanced retention of polar and non-polar compounds, the ACQUITY Premier HSS T3 columns are able to retain and separate various analytes in cell culture media such as TCA acids, vitamins, nucleic acids/bases, and nucleotides in reversed-phase chromatography and compatible with 100% aqueous mobile phases.

  • Cell Culture Media Analysis
  • Product Quality Attributes Monitoring

Accurate amino acid composition analysis

Accurate amino acid composition analysis
AccQ∙Tag Ultra Derivatization Kit

Easily analyze amino acids with manual and automated solutions that use pre-column derivatization with AccQ∙Tag Ultra from Waters, including the Amino Acid Cell Culture Standard Kit.

  • Cell Culture Media Analysis
  • Product Quality Attributes Monitoring

Achieve analytical efficiencies with precise and accurate results leveraging streamlined Waters services and support.

Achieve analytical efficiencies with precise and accurate results leveraging streamlined Waters services and support.

Your success is just a click away

Your success is just a click away
Waters Global Services

Optimize your laboratory's productivity and success with Waters Global Services. Maintain peak system performance, minimize downtime, address application challenges, and support stringent compliance requirements.

  • Cell Culture Media Analysis
  • Product Quality Attributes Monitoring

Make science more accessible

Make science more accessible
Payment Solutions

Maximize resources and minimize risk with payment options from Waters Capital, including upgrading aging equipment, getting customized support, and bundling services into one monthly payment. 

  • 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 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 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.
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 
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
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  • Brochure

Connected Upstream Bioprocessing

Connected Upstream Bioprocessing
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  • Brochure

Bioprocess Walk-Up Solutions

Bioprocess Walk-Up Solutions
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  • Blog

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

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

Faster Upstream Processes vis Direct CQA and Media Analysis Results

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

Pushing the Boundaries of Chromatography for Ultra-Fast Bioseparations

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

Streamlining Glycan Analysis: From Sample Preparation to Data Analysis

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

Bioprocess Walk-Up Solutions Pre-Installation Checklist

Bioprocess Walk-Up Solutions Pre-Installation Checklist
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Bioprocessing
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Learn more about Upstream Bioprocessing Solutions.

Learn more about Upstream Bioprocessing Solutions.
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