Overview of Antibody Drug Thermal Stability Analysis Services

Analysis of the heat stability of antibody drugs is a key link in ensuring drug quality, safety, and efficacy. Heat stability research involves exposing antibody drugs to different temperature conditions and then assessing changes in their structure, function, and biological activity. 

 

Service Purpose

1. Stability Assessment

Determine the stability of antibody drugs at different temperatures and predict their performance under actual usage conditions.

 

2. Drug Safety and Effectiveness

Unstable drugs can lead to degradation, aggregation, or inactivation, affecting the safety and efficacy of the drug.

 

Technical Methods

1. Differential Scanning Calorimetry (DSC)

Determine the heat stability of the protein by measuring the heat absorbed or released by the sample during heating.

 

2. Dynamic Light Scattering (DLS)

Measures the size and distribution of protein aggregation.

 

3. Circular Dichroism (CD)

Assesses the impact of temperature changes on the secondary structure of antibody drugs.

 

4. Infrared Spectroscopy (IR) Analysis

Provides detailed information on the structure of the drug protein.

 

Data Processing and Interpretation

1. Denaturation Temperature (Tm)

Determine the temperature at which the drug protein begins to denature.

 

2. Aggregation Analysis

Evaluate whether the drug forms aggregates at different temperatures.

 

3. Protein Structure Changes

Analyze the impact of temperature on protein structure.

 

Service Report

1. Original Data and Analysis Results

2. Heat Stability Parameters of Antibody Drugs

3. Suggested Storage and Transportation Conditions

4. Expected Shelf-Life of the Drug

 

Application and Significance

1. Drug Formulation Design

Optimize the formulation to improve the heat stability of the drug.

 

2. Optimization of Storage and Transportation Conditions

Determine the optimal storage and transportation conditions to maintain the stability and activity of the drug.

 

3. Quality Control and Regulatory Compliance

Ensure that the drug meets the regulatory requirements for stability.

 

Heat-stability analysis of antibody drugs is a key step in ensuring the quality and efficacy of biological drugs, and is crucial for the development, manufacturing, and final clinical application of the drug. MtoZ Biolabs establishes seven testing platforms, equipped with the MicroCal VP-Capillary DSC system from Malvern Panalytical. This automated, integrated high-throughput platform can be used for:

(1) Identifying and selecting the most stable proteins or potential candidate drugs in the process of biological therapeutic drug development.

(2) Ligand interaction studies.

(3) Rapid optimization of purification and production conditions.

(4) Easy, rapid determination of optimal conditions for liquid formulations.

(5) Rapid stability indicator analysis of target proteins used for screening.