Host Cell Protein Analysis Solutions

Host Cell Protein Analysis Solutions

Waters streamlined LC-MS workflows offer analysts the ability to discover and monitor host cell proteins (HCPs) at ppm levels during the development and production of biotherapeutics to identify potential immunogenic triggers, ensure patient safety, and meet regulatory compliance requirements.

Waters streamlined LC-MS workflows offer analysts the ability to discover and monitor host cell proteins (HCPs) at ppm levels during the development and production of biotherapeutics to identify potential immunogenic triggers, ensure patient safety, and meet regulatory compliance requirements.
antibody medical science microbiology
antibody medical science microbiology

Overview

HCPs are endogenous, process-related impurities derived from expression systems during biotherapeutic production. Even at trace levels (0.1–100 ppm), these impurities have the potential to produce unwanted immunogenic response in patients, or can reduce the safety, efficacy or stability of the therapeutic. For these reasons, regulatory agencies require that HCPs be identified, quantified, and controlled prior to drug approval.

Partner with Waters to improve your HCP identification and quantification with a wide dynamic range, high resolution LC-MS workflows. Confidently identify and monitor HCP variation from many manufacturing and purification conditions, ensuring patient safety while meeting regulatory compliance requirements.

Applications

UPLC-MS assays effectively detect and measure HCPs by integrating high-resolution mass spectrometry (HRMS) with ultra performance LC separation. Data independent acquisition (MSE) enables high-throughput monitoring of HCP variation across a variety of peptides. Learn how this in-depth and sensitive methodology from Waters streamlines identification and quantitation of low-level HCPs for product development or clinical release.

UPLC-MS assays effectively detect and measure HCPs by integrating high-resolution mass spectrometry (HRMS) with ultra performance LC separation. Data independent acquisition (MSE) enables high-throughput monitoring of HCP variation across a variety of peptides. Learn how this in-depth and sensitive methodology from Waters streamlines identification and quantitation of low-level HCPs for product development or clinical release.

Application Notes

Application Notes

Fast, robust, and simple workflows for HCP identification and quantification allow monitoring of impurity clearance, helping to streamline process development activities. Learn how these convenient, quantitative applications from Waters facilitate HCP monitoring during manufacturing and purification to enable development of safe, effective processes.

Fast, robust, and simple workflows for HCP identification and quantification allow monitoring of impurity clearance, helping to streamline process development activities. Learn how these convenient, quantitative applications from Waters facilitate HCP monitoring during manufacturing and purification to enable development of safe, effective processes.

Application Notes

Application Notes

Solutions

Streamline your analysis and improve sample throughput with highly specific biopharmaceutical analysis systems in real time.

Streamline your analysis and improve sample throughput with highly specific biopharmaceutical analysis systems in real time.

Ultimate power, ultimate performance. Redefine the boundaries of science.

Ultimate power, ultimate performance. Redefine the boundaries of science.
SELECT SERIES Cyclic IMS

Combine novel cyclic ion mobility separation with state-of-the-art high-performance, time-of-flight mass spectrometry with the SELECT SERIES Cyclic IMS, enabling researchers to reliably identify and monitor HCPs at low levels.

  • HCP Discovery Workflows

Ion mobility enabled high resolution mass spectrometry

Ion mobility enabled high resolution mass spectrometry
SYNAPT XS

Confidently identify and monitor HCPs during product development with the SYNAPT XS that combines flexible ion mobility separation with high-performance, time-of-flight mass spectrometry.

  • HCP Discovery Workflows

Routine identification for process development

Routine identification for process development
Xevo G3 QTof

Accelerate routine HCP identification with the Xevo G3 QTof high-performance HRMS benchtop system that delivers accurate qualitative and quantitative results.

  • HCP Analysis for Process Development

For efficient HCP monitoring throughout process development

For efficient HCP monitoring throughout process development
BioAccord LC-MS System

Enable routine HCP monitoring for process development with Waters BioAccord LC-MS System that includes high-resolution MS and waters_connect software for compliance-ready data analysis and reporting.

  • HCP Analysis for Process Development

Obtain critical data—whether identifying protein impurities or developing host cell protein databases—with Waters powerful software solutions.

Obtain critical data—whether identifying protein impurities or developing host cell protein databases—with Waters powerful software solutions.

Accelerating HCP analysis

Accelerating HCP analysis
waters_connect for biopharmaceuticals

Streamline HCP analysis workflows for process development and unite LC-MS systems across organizations with waters_connect for biopharmaceuticals, a compliant-ready, networked informatics platform.

  • HCP Analysis for Process Development

Quantitative and qualitative LC-MS research platform

Quantitative and qualitative LC-MS research platform
MassLynx High-Resolution Applications

Identify and quantify your HCP samples with Waters MassLynx Software, designed for high-resolution mass spectrometry data analysis that improves your ability to capture data, secure information, and share knowledge.

  • HCP Discovery Workflows

Quantitative and qualitative LC-MS research platform

Quantitative and qualitative LC-MS research platform
Progenesis QI for Proteomics

Identify and quantify proteins in complex samples with Progenesis QI for Proteomics. With a highly visual guided workflow, Progenesis QI for Proteomics enables you to rapidly profile HCPs to ensure product safety.

  • HCP Discovery Workflows

Columns and consumables that deliver leading-edge LC-MS performance for host cell protein analysis.

Columns and consumables that deliver leading-edge LC-MS performance for host cell protein analysis.

Maximize sensitivity while minimizing metal adsorption of tryptic peptides from your host cell protein digests

Maximize sensitivity while minimizing metal adsorption of tryptic peptides from your host cell protein digests
MaxPeak Premier Peptide Columns

Gain enhanced recovery and sensitivity for tryptic peptides with Waters ACQUITY, XSelect, and XBridge Premier Peptide Columns that are QC batch-tested with Waters Cytochrome c Digest Standard for increased column-to-column performance consistency.

  • HCP Discovery Workflows
  • HCP Analysis for Process Development

Achieve quick, clean, and complete host cell protein digestion

Achieve quick, clean, and complete host cell protein digestion
RapiZyme Trypsin, Mass Spectrometry (MS) Grade

Achieve quick, clean, and complete host cell protein digestions in just 30 minutes with RapiZyme Trypsin, Mass Spectrometry (MS) Grade, a highly active autolysis-resistant enzyme that reduces the likelihood of artificial modifications occurring during sample preparation prior to LC-MS analysis.

  • HCP Discovery Workflows
  • HCP Analysis for Process Development

Enhance the quality of in-solution enzymatic host cell protein digestions  

Enhance the quality of in-solution enzymatic host cell protein digestions  
RapiGest SF Surfactant

Radically enhance the speed and percent recovery of protein enzymatic digestions with  RapiGest SF Surfactant, an anionic surfactant that accelerates the in-solution production of peptides generated by proteases, such as Trypsin, Asp-N, Glu-C, Lys-C, and PNGase F. RapiGest SF is an MS-compatible mild protein denaturant that helps solubilize and unfold proteins, making them more amenable to cleavage without denaturing or inhibiting common proteolytic enzymes like conventional denaturants.

  • HCP Discovery Workflows
  • HCP Analysis for Process Development

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 down time, address application challenges, and support stringent compliance requirements.

  • HCP Discovery Workflows
  • HCP Analysis for Process Development

Make science more accessible with Waters Capital

Make science more accessible with Waters Capital
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.

  • HCP Discovery Workflows
  • HCP Analysis for Process Development

The data speaks for itself

The data speaks for itself
HCP monitoring assay for process development shows summary plots of spiked peptides, all detected with similar detection limits to process development discovery assay.
Extracted mass chromatograms for two low abundance HCP peptides identified in NIST mAb digest using process development discovery HCP assay.

Webinars and Resources

  • Poster

Data Independent LC-MS Assays for Identification, Quantification, and Monitoring of Host Cell Proteins in Monoclonal Antibodies

Data Independent LC-MS Assays for Identification, Quantification, and Monitoring of Host Cell Proteins in Monoclonal Antibodies
Download

Related

Intact and Subunit Protein Analysis Solutions
Evaluate protein identity, glycoforms, and modifications with intact mass and subunit mass spectrometry techniques in Waters solutions for understanding protein structures and advancing biopharmaceutical research.

Peptide Mapping
Achieve unmatched resolution of complicated protein digests, exceptional glycopeptide resolution, and shorter analysis times with UPLC separations and optimally selective and resolving peptide separation chemistries.

Learn more about Host Cell Protein Analysis Solutions.

Learn more about Host Cell Protein Analysis Solutions.
antibody medical science microbiology
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