Antibody Deamidation and Isomerization Analysis Service

In biopharmaceutical research, maintaining the chemical stability of antibodies is essential for their therapeutic efficacy and safety. Key chemical modifications impacting antibody integrity include deamidation and isomerization. Deamidation, occurring predominantly at aspartic and glutamic acid residues in monoclonal antibodies (mAbs), results in isoaspartate or isoglutamate formation. These alterations can modify the antibodies' charge and structure, thereby influencing their antigen-binding efficacy and overall biological functions. Additionally, deamidation can increase the immunogenicity of antibodies, potentially leading to adverse immune responses. Isomerization, the spontaneous transformation of aspartic acid residues into their isomer isoaspartate, is influenced by storage conditions and pH levels, affecting both the structural stability and therapeutic performance of the antibodies. Accurate monitoring and analysis of deamidation and isomerization are therefore vital for assessing the storage stability, safety, and efficacy of antibody medications.

 

MtoZ Biolabs provides sophisticated analytical services for antibody deamidation and isomerization using high-performance liquid chromatography (HPLC) and mass spectrometry (MS), allowing for precise analysis of these chemical modifications. This approach enables the identification and quantification of crucial chemical changes, supporting researchers in evaluating the stability and function of antibody products.

 

Analysis Workflow

1. Sample Preparation

Collect and prepare diverse types of antibody samples, including recombinant and mAbs, for analysis.

 

2. Protein Digestion

Utilize specific enzymes to decompose antibody proteins into peptides, setting the stage for detailed analysis.

 

3. Peptides Separation

Employ HPLC to segregate peptides, enhancing the identification of deamidation and isomerization sites.

 

4. MS Identification and Quantification

Apply MS to meticulously identify and quantify peptides post-HPLC separation.

 

5. Data Analysis

Analyze and interpret the data using bioinformatics tools to understand the impact of the modifications on antibody functionality.

 

Service Advantages

High Precision: Precisely measure the extent of chemical modifications, detecting minimal levels of changes, thereby ensuring the accuracy and reliability of analysis results.

 

High Throughput: Process multiple samples simultaneously, facilitating a faster research workflow.

 

In-depth Data Analysis: Offer comprehensive reports detailing the exact locations and characteristics of the modifications.

 

Quick Turnaround: The entire workflow, from sample receipt to report generation, is completed within a few days.

 

Applications

1. Drug Development

In early drug development phases, by analyzing mAb deamidation and isomerization, timely adjustments to protein expression or purification processes can be made, enhancing drug design.

 

2. Quality Control

Continuously assess antibody deamidation and isomerization throughout production to maintain batch stability and uniformity.

 

3. Formulation Optimization

Modify buffer types and concentrations in formulations based on analytical findings to prevent adverse chemical modifications and extend drug longevity.

 

4. Storage Condition Assessment

Evaluate mAb deamidation and isomerization under various storage conditions to establish optimal conditions.

 

Deliverables

1. Experimental Procedures

2. Relevant Mass Spectrometry Parameters

3. Detailed Information on Antibody Deamidation and Isomerization Analysis

4. Mass Spectrometry Images

5. Raw Data