Biophysical Characterization

Biophysical Characterization

Quickly understand the physical and chemical properties of both biological and non-biological complex drugs with Waters comprehensive range of systems, solutions, and support. Partnering with Waters helps ensure that all drugs in development and manufacturing meet rigorous regulatory guidelines for safety, quality, and efficacy.

Quickly understand the physical and chemical properties of both biological and non-biological complex drugs with Waters comprehensive range of systems, solutions, and support. Partnering with Waters helps ensure that all drugs in development and manufacturing meet rigorous regulatory guidelines for safety, quality, and efficacy.
Cells and biological chain of molecules
Cells and biological chain of molecules

Overview

During the development and production of modern therapeutics—encompassing both biological and non-biological complex drugs—various analytical challenges arise. It is essential to achieve accurate, rapid, and rigorous quantitative results to successfully deliver these products to patients.

The Waters, Wyatt Technologies, and TA Instruments portfolio offers a comprehensive range of systems, solutions, and support to enhance your capability in obtaining detailed biophysical characterization throughout the development cycle. From discovery and cell line development to formulation and quality control, Waters has you covered.

Applications

Accurate binding affinity measurements are crucial in the drug discovery process. Isothermal titration calorimetry (ITC) and composition-gradient multi-angle light scattering (CG-MALS) are label-free and immobilization-free techniques for the accurate measurement of both specific and non-specific binding interactions. ITC provides the complete thermodynamic binding profile to understand the driving forces behind the interaction and CG-MALS provides the absolute stoichiometry beyond the 1:1 interaction model by measuring molar mass.

Accurate binding affinity measurements are crucial in the drug discovery process. Isothermal titration calorimetry (ITC) and composition-gradient multi-angle light scattering (CG-MALS) are label-free and immobilization-free techniques for the accurate measurement of both specific and non-specific binding interactions. ITC provides the complete thermodynamic binding profile to understand the driving forces behind the interaction and CG-MALS provides the absolute stoichiometry beyond the 1:1 interaction model by measuring molar mass.

Application Notes

Developability assessment reduces the risk of costly failures. Differential scanning calorimeters (DSC) and dynamic light scattering (DLS)/ static light scattering (SLS) instruments provide complementary techniques to assess the stability of biotherapeutics during candidate selection and formulation screening. DSC provides a complete thermodynamic metric of protein unfolding, while DLS/SLS instruments supply critical information on the onset of aggregation.

Developability assessment reduces the risk of costly failures. Differential scanning calorimeters (DSC) and dynamic light scattering (DLS)/ static light scattering (SLS) instruments provide complementary techniques to assess the stability of biotherapeutics during candidate selection and formulation screening. DSC provides a complete thermodynamic metric of protein unfolding, while DLS/SLS instruments supply critical information on the onset of aggregation.

Application Notes

Assessing and preventing biotherapeutic aggregation is crucial for FDA approval due to their potentially harmful impact on immunogenic response or activity. High-throughput and automatable DLS/SLS/ electrophoretic light scattering (ELS) techniques enable rapid size and aggregation screening and stability studies. In addition, size exclusion chromatography with multi-angle static light scattering (SEC-MALS) and SEC-mass spectrometry (MS) provides detailed characterization for formulation development. Waters offers QC-ready solutions for these assessments.

Assessing and preventing biotherapeutic aggregation is crucial for FDA approval due to their potentially harmful impact on immunogenic response or activity. High-throughput and automatable DLS/SLS/ electrophoretic light scattering (ELS) techniques enable rapid size and aggregation screening and stability studies. In addition, size exclusion chromatography with multi-angle static light scattering (SEC-MALS) and SEC-mass spectrometry (MS) provides detailed characterization for formulation development. Waters offers QC-ready solutions for these assessments.

Application Notes

Real-time MALS monitors product attributes during downstream purification and enrichment methods such as IEX, fast protein liquid chromatography (FPLC), and tangential flow filtration (TFF) to enhance quality and maximize yield. For product development, DSC provides the glass transition temperature, which is essential for the lyophilization process and formulation stability. Rheology further optimizes the fill-and-finish process, ensuring accurate dosage and product consistency.

Real-time MALS monitors product attributes during downstream purification and enrichment methods such as IEX, fast protein liquid chromatography (FPLC), and tangential flow filtration (TFF) to enhance quality and maximize yield. For product development, DSC provides the glass transition temperature, which is essential for the lyophilization process and formulation stability. Rheology further optimizes the fill-and-finish process, ensuring accurate dosage and product consistency.

Application Notes

eBook: Characterization of Biologics and Complex Drugs

While developing and producing modern therapeutics—both biological and non-biological complex drugs—numerous analytical challenges emerge. Obtaining quantitative results accurately, rapidly, and rigorously is crucial for successfully bringing these products to patients.

Explore our end-to-end solutions for advanced characterization of antibodies and protein-based therapies, vaccines, gene therapies, nanomedicines, peptides, and nucleic acids.

While developing and producing modern therapeutics—both biological and non-biological complex drugs—numerous analytical challenges emerge. Obtaining quantitative results accurately, rapidly, and rigorously is crucial for successfully bringing these products to patients.

Explore our end-to-end solutions for advanced characterization of antibodies and protein-based therapies, vaccines, gene therapies, nanomedicines, peptides, and nucleic acids.

View eBook
Virus and antibodies in blue and yellow

Solutions

TA Instruments and Wyatt Technology systems deliver unmatched sample reproducibility with the highest sensitivity, innovative technology, and industry-proven reliability.

TA Instruments and Wyatt Technology systems deliver unmatched sample reproducibility with the highest sensitivity, innovative technology, and industry-proven reliability.

Confidently study molecular interactions

Confidently study molecular interactions
Affinity ITC

Measure a wide variety of molecular interactions with the Affinity ITC, designed for the most challenging life science applications that require high sensitivity and high productivity for the highest quality isothermal titration calorimetry (ITC) data.

  • Binding Interactions and Thermodynamics

Unmatched flexibility for characterizing molecular structure and stability

Unmatched flexibility for characterizing molecular structure and stability
Nano DSC

Quantify the thermal stability of large biomolecules and biotherapeutics with the Nano DSC that quickly measures the heat of reaction from tertiary and secondary structure changes occurring when a biomolecule unfolds or melts in nucleic acids and lipids.

  • Thermal Stability and Higher-Order Structure
  • Binding Interactions and Thermodynamics

The next generation of thermal stability testing for biologic drugs

The next generation of thermal stability testing for biologic drugs
RS-DSC

The TA Instruments RS-DSC (Rapid Screening-Differential Scanning Calorimeter) is a powerful instrument that revolutionizes the thermal stability testing of high-concentration biologic drugs with its high efficiency and streamlined analysis.

  • Thermal Stability and Higher-Order Structure

World’s finest line of differential scanning calorimeters

World’s finest line of differential scanning calorimeters
Discovery DSC

The DSC 2500 with Modulated DSC and patented T4P Tzero heat flow delivers the highest sensitivity and resolution to obtain accurate results every time for your lyophilization optimization needs.

  • Process Development

Sensitivity, ease-of-use, and versatility to exceed your expectations

Sensitivity, ease-of-use, and versatility to exceed your expectations
Discovery Hybrid Rheometer

Understand the flow properties of your biologic formulations with the HR 20 for injectability and fill and finish applications for more than just viscosity.

  • Process Development

Uniquely versatile detector for every developmental stage

Uniquely versatile detector for every developmental stage
DAWN

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 biosimilar protein-conjugate ratio, post-translational modifications, and aggregation.

  • Binding Interactions and Thermodynamics
  • Process Development
  • Size and Aggregation

Measure size and zeta potential in native buffer

Measure size and zeta potential in native buffer
DynaPro ZetaStar

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.

  • Thermal Stability and Higher-Order Structure
  • Size and Aggregation

High throughput size and stability screening

High throughput size and stability screening
DynaPro DLS Plate Reader

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

  • Thermal Stability and Higher-Order Structure
  • Size and Aggregation
  • Process Development

Increase yield and monitor product quality with confidence

Increase yield and monitor product quality with confidence
ultraDAWN

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

  • Process Development

The next evolution in separation science is here

The next evolution in separation science is here
ACQUITY Premier System

Gain improvements in separation and detection of metal-sensitive analytes with the ACQUITY Premier System featuring MaxPeak High Performance Surfaces (HPS) Technology, enabling you to minimize the risk of undetected analytes.

  • Size and Aggregation

Compliance-ready, networkable applications-based software to streamline data acquisition, processing, and reporting.

Compliance-ready, networkable applications-based software to streamline data acquisition, processing, and reporting.

Simplify data acquisition, processing, and reporting

Simplify data acquisition, processing, and reporting
Empower Chromatography Data System (CDS)

Equip your lab with Empower Chromatography Data System (CDS) and gain advanced laboratory data management for your biophysical characterization, including acquisition, processing, and reporting.

  • Size and Aggregation

The ultimate in light scattering software

The ultimate in light scattering software
ASTRA

Obtain the most powerful and versatile software available for the characterization of macromolecules via multi-angle and dynamic light scattering with ASTRA. Optional 21CFRp 11 and EUAnnex11 security package is available.

  • Size and Aggregation
  • Process Development

The most comprehensive suite of tools for ITC and DSC control and analysis

The most comprehensive suite of tools for ITC and DSC control and analysis
ITCRun, DSCRun, & NanoAnalyze Software

Designed with intuitive user interfaces, the individual software packages allow for quick creation and execution of experiments and robust analysis of data while maintaining focus on the task at hand. Optional 21CFRp 11 package available.

  • Binding Interactions and Thermodynamics
  • Thermal Stability and Higher-Order Structure

One comprehensive thermal analysis and rheology software solution

One comprehensive thermal analysis and rheology software solution
TRIOS

TA Instruments robust software package uses innovative technology for instrument control, data collection, data analysis, and reporting for thermal analysis and rheology. Activate Guardian to meet all your regulation needs.

  • Process Development

Columns and consumables that deliver leading-edge performance for biophysical characterization.

Columns and consumables that deliver leading-edge performance for biophysical characterization.

More confident size variant separations

More confident size variant separations
ACQUITY and XBridge Premier Protein SEC 250 Å Columns

Minimize secondary ionic or hydrophobic interactions in size-based separations with ACQUITY and XBridge Premier Protein SEC 250Å Columns with MaxPeak High Performance Surface (HPS) Technology for reliable protein aggregate, monomer, and fragment analyses using a “platform” type method with 30% increase in resolution. 

  • Size and Aggregation

Achieve testing efficiencies and accurate results using streamlined Waters services and support.

Achieve testing efficiencies and accurate results using 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.

  • Binding Interactions and Thermodynamics
  • Thermal Stability and Higher-Order Structure
  • Process Development
  • Size and Aggregation

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.

  • Binding Interactions and Thermodynamics
  • Thermal Stability and Higher-Order Structure
  • Process Development
  • Size and Aggregation

The data speaks for itself

The data speaks for itself
Characterize aggregates and fragments with SEC-MALS. Aided by the superb separation power of UPLC, SEC-MALS identifies and quantifies the peaks observed for a degraded mAb, in terms of molecular weight and total eluting mass. Fragments such as dual and single heavy chains, and small oligomers such as dimers consisting of monomer + fragments, are found.
An ITC experiment can rapidly quantify the exothermic or endothermic non-covalent binding of two proteins. When two proteins interact and bind, conformational changes in the proteins, and rearrangement of the solvent in the vicinity of the binding site, result in the absorption or generation of heat. Quantification of this reaction heat by ITC provides a complete thermodynamic description of the binding interaction, the stoichiometry of binding, and the association constant; in addition, if structural information is available, the contributions of specific amino acids mediating the binding event can be identified and their thermodynamic contributions quantified.
Antibody DSC Thermogram. Deconvolute each domain with typical unfolding as follows: CH2, Fab, CH3.
Overlay of replicate data from screening of Herceptin Trastuzumab in histidine, borate, PBS, and succinate buffer. Data collected in triplicate at an antibody concentration of ~20 mg/mL with a scan rate of 1 °C/min. Identify which buffers to move forward with in development by looking at Tonset and TM.
Modulated DSC (MDSC) data for 40% sucrose/water solution. Identify the glass transition for lyophilization in complex samples by separating out the reversible (heat capacity) and irreversible (kinetic events) heat signals.
HT-DLS provides more sizing and aggregation data, on more samples and more formulations with far less effort.
XBridge Protein SEC 250 Å, 2.5 µm particles were packed into both hydrophilic MaxPeak High Performance Surfaces hardware (left) and conventional stainless steel hardware (right) to clearly demonstrate the benefit afforded by the HPS hardware. Excellent monomer peak shape and HMWS recovery for NISTmAb (RM 8671) was achieved with the hydrophilic MaxPeak HPS Column, even at low NaCl concentrations.

Webinars and Resources

  • Brochure

Microcalorimetry: RS-DSC, DSC & ITC 

Microcalorimetry: RS-DSC, DSC & ITC 
Download
  • Brochure

Guide to Size-Exclusion Chromatography (SEC) of mAb Aggregates, Monomers, and Fragments

Guide to Size-Exclusion Chromatography (SEC) of mAb Aggregates, Monomers, and Fragments
Download
  • eBook

Must Know Analytical Techniques for Biopharma Developers

Must Know Analytical Techniques for Biopharma Developers
Download
  • eBook

Characterization of Biologics and Complex Drugs

Characterization of Biologics and Complex Drugs
Download
  • Webinar

Towards Well-Characterized Proteins and Protein Conjugates Using SEC-MALS

Towards Well-Characterized Proteins and Protein Conjugates Using SEC-MALS
Watch
  • Webinar

Real-Time Monitoring of AAV CQAs in a Chromatographic Polishing Step

Real-Time Monitoring of AAV CQAs in a Chromatographic Polishing Step
Watch
  • Webinar

Biophysical Characterization of Antibody Drug Conjugates Using DSC

Biophysical Characterization of Antibody Drug Conjugates Using DSC
Watch
  • Webinar

Advanced Characterization of Antibody-Drug Conjugates and Antibody-Fusion Proteins

Advanced Characterization of Antibody-Drug Conjugates and Antibody-Fusion Proteins
Watch
  • Webinar

Introducing the RS-DSC: Dilution Free Screening of High Concentration Biotherapeutics

Introducing the RS-DSC: Dilution Free Screening of High Concentration Biotherapeutics
Watch

Related

Biologics Development Solutions - TA Instruments
TA Instruments | Waters Corporation offers a suite of reliable solutions that are essential for ensuring desired product quality and guaranteeing safety and efficacy in the biopharmaceutical industry.

Learn more about Biophysical Characterization Solutions.

Learn more about Biophysical Characterization Solutions.
细胞和生物分子链
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