Therapeutics Characterization Service | Advanced Structure
With the growing importance of biologics such as therapeutic proteins and monoclonal antibodies, comprehensive therapeutics characterization has become essential for ensuring their safety, efficacy, and consistency. This includes advanced structure characterization, which involves evaluating secondary and tertiary structures, aggregation, and conformational stability. MtoZ Biolabs offers a multi-platform solution integrating mass spectrometry, spectroscopy, thermal analysis, and light scattering to support quality assessment, formulation, and regulatory needs.
Services at MtoZ Biolabs
To accommodate diverse research needs, MtoZ Biolabs offers a therapeutics characterization service classified by both technical platforms and structural characterization dimensions.
| Therapeutics Advanced Structure Characterization Platform | DSC and TGA Analysis Service |
| FT-IR | |
| Dynamic Light Scattering (DLS) | |
| Hydrogen Deuterium Exchange Mass Spectrometry | |
| Circular Dichroism (CD) | |
| X-ray Crystal Diffraction | |
| Cryo-EM | |
| Therapeutics Advanced Structure Characterization Content | Protein Secondary Structure Analysis |
| Disulfide Bond Analysis | |
| Free Sulfhydryl Quantification | |
| Disulfide Bond Mapping | |
| Protein Conformation Analysis | |
| Pharmaceutical Thermal Stability Analysis | |
| Particle Size Distribution Analysis | |
| Dynamic Conformational Change and Function Identification |
Analysis Workflow
1. Project Discussion and Strategy Design
After receiving your request, our technical team will propose an appropriate structure analysis plan.
2. Sample Quality Control and Preparation
Samples are pre-processed to ensure appropriate concentration, buffer compatibility, and analytical readiness.
3. Integrated Multi-Platform Testing
Testing is performed across relevant platforms, including spectroscopy, calorimetry, mass spectrometry, and light scattering.
4. Data Integration and Interpretation
Results are compiled and interpreted, with a comprehensive structural stability report and potential risk assessment delivered.
Service Advantages
1. Multi-Platform Integration
MtoZ Biolabs integrates CD, FT-IR, DSC, mass spectrometry, and light scattering to capture both local structural elements and global conformational dynamics, ensuring a holistic understanding of structural features.
2. Customized Strategies
We tailor our testing workflows based on the molecule type (monoclonal antibodies, fusion proteins, or enzymes) to ensure fit-for-purpose analysis without unnecessary testing.
3. Experienced Team
Our therapeutics characterization service is executed by a team with expertise in protein structural analysis, mass spectrometry method development, and biologics quality assessment. The team’s project experience enables practical insights and reliable data interpretation.
4. One-Time Pricing
Our pricing model is straightforward, with no hidden fees.
Applications
1. Structural verification and screening of protein candidates during early-phase drug development
2. Conformational stability assessment during process optimization
3. Monitoring of aggregation trends in bulk drug substance or final formulation
4. Batch-to-batch consistency validation and quality standard development
5. Structural comparability studies following formulation or process changes
FAQs
Q1: How do I know if my sample is suitable for disulfide bond analysis?
A1: If your protein contains multiple cysteine residues or may be in a reduced state, we recommend disulfide bond mapping combined with free sulfhydryl quantification to confirm structural integrity.
Q2: What is the typical turnaround time for the therapeutics characterization service?
A2: Timelines vary depending on the number and complexity of requested tests. Simple analyses (e.g., CD or DLS) can be completed within 5–7 business days, while multi-platform projects (e.g., DSC + HDX-MS + disulfide mapping) may require 3–6 weeks. We provide a detailed schedule during project planning and offer expedited options when needed.
Sample Submission Suggestions
1. Recommended amount: ≥100 μg protein at ≥0.5 mg/mL concentration
2. Avoid buffers with high concentrations of glycerol, urea, or strong reducing agents
3. Please indicate if the sample contains tags or chemical modifications
4. For multi-method testing, consider submitting pre-aliquoted vials to avoid freeze-thaw cycles
5. We can provide a detailed submission guideline to support your preparation
Deliverables
1. Raw data files (e.g., spectra, thermal curves, MS profiles)
2. Structured interpretation report detailing the tested dimensions and structural findings
3. Conformational stability insights with risk annotations
4. Description of analytical methods and experimental conditions
5. Optional data integration and regulatory-support documentation (e.g., IND summary format)
Advanced structure characterization is a foundational yet critical element in the development and evaluation of therapeutic biologics. At MtoZ Biolabs, we uphold scientific rigor through multi-platform integration to provide comprehensive, reliable, and application-ready structural insights.
If you're interested in our therapeutics characterization service or have questions about advanced structure characterization of biologics, feel free to contact MtoZ Biolabs. Our dedicated project managers are ready to provide technical consultation, project planning, and sample submission guidance to help you move forward with confidence.
Related Services
How to order?
