Sequence Variation Identification Between Monoclonal Antibodies and Generic Drugs Service

Monoclonal antibodies (mAbs) represent a class of antibodies that exhibit high specificity towards specific antigens, making them invaluable in the treatment of various conditions such as cancer, inflammatory diseases, and autoimmune disorders. With the expiration of patents for original biologics and the escalating costs associated with biopharmaceutical development, generic drugs have emerged as cost-effective alternatives. Generic drugs are biologic medical products that are highly similar to an already approved original product in terms of quality, safety, and efficacy. Nonetheless, variations in production methodologies and host cell systems may introduce minor differences in amino acid sequences and post-translational modifications (PTMs). The precise identification and characterization of these variations are essential to maintain the generic drugs' quality and therapeutic efficacy.

MtoZ Biolabs has established an advanced antibody sequencing platform leveraging liquid chromatography-mass spectrometry (LC-MS). This platform is designed to deliver highly accurate sequence variation identification services for both mAbs and generic drugs. Utilizing this technology, we can meticulously identify and quantify various PTMs such as glycosylation, phosphorylation, and oxidation, in addition to detecting low-abundance impurities and unexpected amino acids.

Analysis Workflow

1. Sample Preparation

The target protein is meticulously extracted from the supplied samples, followed by appropriate pre-treatment procedures.

2. Enzymatic Digestion

The samples undergo enzymatic digestion using multiple proteases to produce peptide fragments amenable to mass spectrometric analysis.

3. LC-MS Analysis

The peptides are first separated via liquid chromatography and subsequently subjected to precise measurement using tandem mass spectrometry.

4. Data Processing

The resulting mass spectrometric data are processed using sophisticated automated software to identify sequence variations and PTMs.

5. Report Generation

Comprehensive analysis reports are generated, detailing the sequence variations, PTM identifications, and quantification results.

Service Advantages

High Coverage: Multiple digestions ensure 100% sequence coverage.

High Sensitivity: Capable of detecting mutations as low as 0.1%.

Integrated Service: Includes sequence variation identification, PTM analysis, and glycosylation analysis.

Expert Team: Experienced scientists providing customized solutions and detailed reports.

Sample Submission Requirements

Sample Quantity: A minimum of 100 μg of purified protein is necessary.

Sample Purity: The purity of the samples should be at least 90%.

Applications

1. Generic Drugs Development

Ensures sequence consistency between generic drugs and original biologics, thereby confirming biosimilar quality.

2. Quality Control

Facilitates the monitoring of product quality throughout the production process, detecting low-abundance impurities and sequence variations.

3. Drug Development

Enables the analysis of PTM differences in candidate drugs, optimizing both drug design and process development.

4. Regulatory Submission

Provides detailed reports on sequence variations and PTMs to support regulatory submissions and compliance requirements.