Expert Monoclonal Antibody Analysis

Monoclonal antibodies (mAbs) are complex, high-value antibody-based therapeutic drugs used across a broad range of indications, from oncology and immunology to infectious disease. Whether innovator or biosimilar, all therapeutic monoclonal antibody products require thorough protein sequencing and structural characterization to meet regulatory expectations and ensure product safety, stability and efficacy.

BioPharmaSpec scientists have been characterizing recombinant monoclonal antibodies for over three decades. We offer end-to-end monoclonal antibody analysis services including de novo protein sequencing, and analysis of primary, secondary and tertiary structural features including post-translational modifications. BioPharmaSpec also offers investigations into product and process related impurities, such as aggregation and Host Cell Proteins (HCPs). Through this comprehensive range of mAb characterization analyses, BioPharmaSpec scientists support every stage of your drug development process.

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Why Characterize Your Monoclonal Antibody?

Accurate protein sequencing and characterization of the physicochemical properties of your therapeutic monoclonal antibody (mAb) is a critical first step in ensuring the long-term value, functionality and developability of your therapeutic candidate. Whether you are working with hybridoma-derived or recombinant antibodies, knowing the amino acid protein sequence and structure of your high molecular weight antibody molecule is essential. As drug development progresses, verifying the structural characteristics of your product ensures the identity, consistency, quality and potential safety of your mAb. This is critical for regulatory filings, biosimilar comparability claims and ongoing process validation.

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Discover how ICH Q6B guidelines apply to monoclonal antibodies, ADCs, and Insulin. Join Dr. Andrew J. Reason as he walks through key characterisation strategies in this on-demand webinar.

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Our mAb Characterization Services

1. Structural Characterization

Primary protein sequencing: (de novo) amino-acid sequence determination using a combination of high-resolution state-of-the-art mass spectrometry (including LC-MS/MS with EAD and ECD fragmentation as necessary) and automated N-terminal Edman sequencing.
Primary structure confirmation: Mass spectrometric peptide mapping and N- and C-terminal amino-acid sequence structure, including assessment of modifications such as pyroGlu.
Disulfide bridge mapping: Confirmation of intra-/inter-chain linkage integrity using Peptide Mapping mass spectrometry.
Glycosylation profiling: Carbohydrate structure using mass spectrometry and chromatographic analysis for N-linked glycans. O-glycan analysis can also be performed if necessary.
Amino acid composition analysis

2. Physicochemical Properties Characterization

Identity and purity
Molecular weight: Intact mass analysis, reduced and de-N-glycosylated profiling of heavy and lights chains using mass spectrometry
Isoform pattern: Charge heterogeneity via icIEF and IEX
Extinction coefficient assessment
Liquid chromatographic patterns
Spectroscopic profiles: Secondary/tertiary and higher order structure, Circular dichroism (CD), FT-IR, DSC
Aggregation assessment: Size exclusion chromatography with multi-angle light scattering (SEC-MALS), sedimentation velocity analytical ultracentrifugation (SV-AUC) and other orthogonal tools as necessary

3. Process-Related Impurity Assessment

When to Use Our Services

Whether you are at early-stage discovery, ongoing drug development or nearing regulatory submission, BioPharmaSpec can provide monoclonal antibody analysis solutions enabling you to:

Confirm the structure and sequence fidelity of your therapeutic candidates, both novel and biosimilar.
Support structural and physicochemical comparability studies for biosimilars.
Meet ICH Q6B and FDA/EMA structural characterization guidelines for monoclonal antibodies.
Investigate sample-related issues that may have arisen from other investigations on the product, such as during stability testing.
Assess product impurities.

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Why Choose Biopharmaspec?

Industry-Leading Expertise: Our scientists have over 30 years of experience in monoclonal antibody characterization across therapeutic classes and expression systems.
High-Confidence Results: For our monoclonal antibody sequencing service we use high-resolution mass spectrometry platforms and qualified in-house workflows to ensure reliable protein sequencing characterization and reproducible monoclonal antibody analysis data.
Regulatory Guideline-Driven Deliverables: Our analytical strategies are developed in line with global regulatory guideline expectations (ICH Q6B, FDA, EMA).
End-to-End Analytical Support: From complete protein sequencing and structural monoclonal antibody analysis to impurity profiling and stability storage analysis to functional testing of biological activity via partnerships, we provide integrated support tailored to the particular stage of your drug development.

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The full characterization of a monoclonal antibody requires a deep knowledge of relevant analytical techniques and the fundamentals of protein structure to generate and contextualize the data. Ensure your project is in the hands of experienced scientists and optimized for success.

Contact us to discuss your monoclonal antibody analysis requirements and any specific questions you may have on characterizing your product.

Frequently Asked Questions

1. What is antibody sequencing, and why is it important for therapeutic development?

2. What sequencing methods are available, and how do I know which is right for my antibody?

At BioPharmaSpec, we primarily use mass spectrometry (LC-MS/MS) to deliver high-confidence, protein sequencing data, including information on relevant post-translational modifications if required.

Our mass spectrometric approach is strengthened by the application of state-of-the-art instrumentation equipped with specific fragmentation processes to definitively identify amino acids that cannot be categorically identified by more traditional fragmentation techniques. Alongside this we also use automated gas phase Edman sequencing where necessary to support the mass spectrometric data.

3. What do I receive in a monoclonal antibody characterization report?

Your monoclonal antibody sequencing service report will include data on key quality features as outlined in your project quotation, which will include all or some of the following depending on your stage of drug development:

Complete amino acid sequence of the heavy and light chains. Protein sequencing using mass spectrometry and automated N-terminal Edman sequencing.
Peptide mapping using mass spectrometry
Post-translational modification investigations
N- and C-terminal amino acid assessment
Amino acid analysis
Extinction coefficient investigation
Disulfide bridge mapping
Glycosylation characterization
Isoform profiling
Capillary gel electrophoretic profiling
Chromatographic profiles from orthogonal chromatographic techniques
Intact mass profiling- intact molecular weight by mass spectrometry
Higher order structural analysis from a variety of orthogonal techniques
Aggregation assessment
Impurity investigations and stability testing analysis

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4. What are the sample requirements?

5. How long does monoclonal antibody analysis take?

The timeline for our monoclonal antibody sequencing service depends on the specifics of the project and factors such as the scope, complexity, and any regulatory or logistical lead times involved. That said, we pride ourselves on being highly responsive and flexible, with fast turnaround times and excellent customer service. Once we understand the details of your requirements, we’ll be able to provide a clear and realistic timeframe. Our goal is always to meet your deadlines without compromising on quality.

6. Can you work with antibodies from any species or isotype?

7. Can you support biosimilar monoclonal antibody development?

Absolutely. As a first step we are able to provide a complete monoclonal antibody sequencing service to initially interrogate target recombinant antibodies. Following on from this we provide comprehensive side-by-side analysis of innovator and biosimilar antibodies, including all of the above analyses, enabling robust comparability studies. We are also able to design on-going analytical studies across a number of campaigns, such that characterization of appropriate batch numbers is achieved to satisfy regulatory authority requirements.

Monoclonal Antibody Characterization Service