Bio-conjugates

Bio-conjugates

Comprehensively characterize the complex, heterogeneous structures of bio-conjugates (including antibody drug conjugates) with Waters fit-for-purpose sample preparation, columns, UPLC, QTof MS, DLS, MALS, and informatics solutions. Waters is committed to supporting the development of safe and effective therapies for cancers and other diseases by helping you generate accurate ADC profiles to characterize and monitor critical quality attributes.

Comprehensively characterize the complex, heterogeneous structures of bio-conjugates (including antibody drug conjugates) with Waters fit-for-purpose sample preparation, columns, UPLC, QTof MS, DLS, MALS, and informatics solutions. Waters is committed to supporting the development of safe and effective therapies for cancers and other diseases by helping you generate accurate ADC profiles to characterize and monitor critical quality attributes.

Develop robust and comparable processes by monitoring profiles of glycopeptides and released N-glycans
Develop robust and comparable processes by monitoring profiles of glycopeptides and released N-glycans

Overview

ADCs are a class of biopharmaceutical drugs that deliver cancer-killing agents directly to cancer cells – a far more targeted approach than conventional chemotherapy. Optimizing ADCs requires analytical technologies to comprehensively characterize the molecule, including its biochemical attributes like drug-to-antibody ratio (DAR) and sites of conjugation.

As biopharmaceutical organizations continue to explore the use of ADCs as a class of cancer therapies, they find significant challenges with analyzing their complex, heterogenous structures. However, a well-characterized ADC is critical to advance from discovery through clinical development and to commercialization.

Successfully address your characterization challenges with exceptional insight into your molecules from Waters fit-for-purpose ultra-performance liquid chromatography (UPLC), high resolution mass spectrometry (MS), column chemistries, and informatics solutions. Trust Waters to help simplify complex molecule analysis and accelerate your ADC characterization and monitoring of critical quality attributes.


Applications

ultraDAWN™ real-time MALS directly monitors product attributes post-purification, enhancing yield and flexibility. It connects downstream purification and enrichment methods, such as IEX, FPLC, or TFF, to measure molecular weight, concentration, size, and impurities\impurities in real-time, streamlining processing and maximizing yield.

ultraDAWN™ real-time MALS directly monitors product attributes post-purification, enhancing yield and flexibility. It connects downstream purification and enrichment methods, such as IEX, FPLC, or TFF, to measure molecular weight, concentration, size, and impurities\impurities in real-time, streamlining processing and maximizing yield.


Application Notes

Application Notes
Scientist holding a test tube next to a bioreactor


Case Study: How Waters is Helping to Support the Development of Novel Therapies

To quickly move an ADC-based therapeutic out of development and into the clinic, Igenica Biotherapeutics wanted industry-standard instrumentation to analyze the complexity and variation within the ADC. This case study describes how Waters solutions, including Waters Biopharmaceutical Platform Solution with UNIFI, provided a superior window of insight into the molecules being developed by Igenica.

To quickly move an ADC-based therapeutic out of development and into the clinic, Igenica Biotherapeutics wanted industry-standard instrumentation to analyze the complexity and variation within the ADC. This case study describes how Waters solutions, including Waters Biopharmaceutical Platform Solution with UNIFI, provided a superior window of insight into the molecules being developed by Igenica.


Closeup of vaccination vial and syringe

Solutions


With Waters systems, characterize complex bio-conjugates in less time and with greater confidence.

With Waters systems, characterize complex bio-conjugates in less time and with greater confidence.

Designed specifically for biopharmaceutical routine monitoring

Designed specifically for biopharmaceutical routine monitoring

Obtain greater simplicity, accuracy, and reproducibility for attribute monitoring of bio-conjugates with the BioAccord LC-MS System.

  • Real-Time Process Monitoring
  • Candidate Screening
  • Chromatography
  • Identity and Post-Translational Modification Analysis
  • Protein-Conjugate Ratio
  • Aggregation and Stability

Complete coverage for confident characterization

Complete coverage for confident characterization

Maximize sample information for your analytes from detailed characterization to accurate quantitation with the Xevo G3 QTof, which enables complete confidence in your bio-conjugates analytical data.

  • Real-Time Process Monitoring
  • Candidate Screening
  • Chromatography
  • Identity and Post-Translational Modification Analysis
  • Protein-Conjugate Ratio
  • Aggregation and Stability

The universal platform for liquid chromatography

The universal platform for liquid chromatography

Eliminate unpredictability of analyte losses due to metal interactions with MaxPeak Premier Solutions, a portfolio of LC, LC-MS, and column chemistries designed to get maximum limits of detection for challenging compounds, without time-consuming tasks like system passivation.

  • Real-Time Process Monitoring
  • Candidate Screening
  • Chromatography
  • Identity and Post-Translational Modification Analysis
  • Protein-Conjugate Ratio
  • Aggregation and Stability

The lowest dispersion system for maximum peak capacity

The lowest dispersion system for maximum peak capacity

Solve your complex UPLC/UHPLC antibody drug conjugate (ADC) separation challenges with ACQUITY UPLC Systems with 2D LC Technology, a family of systems and columns that offer the lowest dispersion for maximum peak capacity.

  • Real-Time Process Monitoring
  • Candidate Screening
  • Chromatography
  • Identity and Post-Translational Modification Analysis
  • Protein-Conjugate Ratio
  • Aggregation and Stability

Uniquely versatile detector for every developmental stage

Uniquely versatile detector for every developmental stage

The DAWN™ MALS detector assists at every development stage. Couple with Eclipse™ to measure binding affinity during discovery. Place downstream of any LC and perform advance analysis of protein-conjugate ratio, post-translational modifications, and aggregation.

  • Candidate Screening
  • Chromatography
  • Identity and Post-Translational Modification Analysis
  • Protein-Conjugate Ratio
  • Aggregation and Stability

Measure size and zeta potential in native buffer

Measure size and zeta potential in native buffer

The DynaPro™ ZetaStar™ instrument combines DLS, SLS, and ELS in one platform. Designed for biopharma in mind, it can measure zeta-potential in formulation buffer without dilution.

  • Aggregation and Stability
  • Chromatography

High-throughput size and stability screening

High-throughput size and stability screening

Measure size, polydispersity, and Tagg data for hundreds of samples with as little as 4µL per well. The DynaPro™ DLS Plate Reader uses standard-well plates; integrate with any liquid handler and further boost productivity.

  • Candidate Screening
  • Aggregation and Stability

Increase yield and monitor product quality with confidence

Increase yield and monitor product quality with confidence

ultraDAWN™ directly monitors titer, size, and impurities in real-time. It connects downstream purification and enrichment methods, such as IEX, FPLC, or TFF.

  • Real-Time Process Monitoring


The data speaks for itself

The data speaks for itself
Cysteine conjugated ADC analysis using HIC. Drug distribution was determined for three different cysteine-conjugated ADC samples with increasing drug load Cysteine conjugated ADC analysis using HIC. Drug distribution was determined for three different cysteine-conjugated ADC samples with increasing drug load.
Gaussian-fitted DSC ADC results collected on the BioAccord System for native (top) and a high DAR mAb (bottom) Gaussian-fitted DSC ADC results collected on the BioAccord System for native (top) and a high DAR mAb (bottom).
Fast SEC analysis of trastuzumab emtansine (A) and bevacizumab (B) as performed on an XBridge Premier Protein SEC 250 Å 2.5 µm 4.6 x 150 mm column. Mobile phase: 1x PBS, pH 7.4, flow rate F = 0.7 mL/min, temperature T = 25 °C, injected volume 1 μL, detection: 280 nm (UV) Fast SEC analysis of trastuzumab emtansine (A) and bevacizumab (B) as performed on an XBridge Premier Protein SEC 250 Å 2.5 µm 4.6 x 150 mm column. Mobile phase: 1x PBS, pH 7.4, flow rate F = 0.7 mL/min, temperature T = 25 °C, injected volume 1 μL, detection: 280 nm (UV).
Peptide Mapping (UV chromatograms) comparison of a conjugated and unconjugated Trastuzumab Peptide Mapping (UV chromatograms) comparison of a conjugated and unconjugated Trastuzumab
Top: Trastuzumab biosimilar tryptic digestion.
Bottom: Trastuzumab emtansine (Kadcyla), antibody drug conjugate tryptic digestion.
Both tryptic digestions utilized RapiZyme Trypsin and PeptideWorks Tryptic Protein Digestion Kit with 100 µL injection (~ 10 µg) on XSelect Premier Peptide CSH C18, 2.5 µm, 2.1 x 150 mm column. Additional peaks observed in Kadcyla chromatogram (bottom) compared to unconjugated trastuzumab (top).

Webinars and Resources



Related

Rely on Waters as your single source solution for antibody drug conjugate (ADC) chromatography columns, designed to provide an accurate drug-to-antibody ratio for discovery, development, and manufacturing applications.

Learn more about Bio-conjugates Solutions.

Learn more about Bio-conjugates Solutions.

Develop robust and comparable processes by monitoring profiles of glycopeptides and released N-glycans
Back To Top Back To Top