Protein Analysis
R&D Research & Development
Advanced mass spectrometry-based protein analysis services for characterization, quantification, and structural assessment.
Advanced protein analysis at the molecular level—including intact molecular weight determination, isoform characterization, glycosylation profiling, drug–protein interaction analysis, and targeted protein quantification—provides the mechanistic insight and quality attribute data essential for the development and quality control of biological therapeutics. High-resolution mass spectrometry has transformed the depth and accuracy of the analytical information available.
AMSbiopharma provides a focused portfolio of advanced protein analysis services, applying high-resolution mass spectrometry together with complementary orthogonal analytical techniques to deliver detailed molecular characterization of therapeutic proteins, antibodies, and other biological entities.
Intact Protein Molecular Weight and Isoform Analysis / Non-GMP
Accurate quantification of drug concentrations in biological matrices is the foundation of every pharmacokinetic programme. Our PK bioanalytical services support pharmacokinetic and preclinical toxicokinetic studies, providing the quantitative data required to characterise drug exposure throughout the development process.
We develop and validate bioanalytical methods for a wide range of biological matrices, including plasma, serum, whole blood, urine, cerebrospinal fluid (CSF), tissue homogenates, and dried blood spots (DBS). Full method development and validation are performed in accordance with ICH M10, covering specificity, selectivity, sensitivity, linearity, accuracy, precision, matrix effects, stability, and dilution integrity.
PK/PD data are delivered in formats compatible with leading pharmacokinetic and pharmacometric modelling software, enabling seamless integration into the sponsor’s development workflows. All studies are conducted under controlled documentation systems aligned with applicable regulatory requirements.
Key analytical capabilities
- Full ICH M10-compliant bioanalytical method development and validation for regulated studies
- Bioanalysis of plasma, serum, urine, CSF, tissue homogenates, and alternative biological matrices
- PK/PD data support for dose selection, exposure assessment, and regulatory submissions
- Applicable to small molecules, therapeutic peptides, biologics, oligonucleotides, and gene therapy vectors
Analysis of Glycopeptides and Released Glycans
Glycosylation is one of the most critical quality attributes of biological therapeutics, with a direct impact on pharmacokinetics, effector function, immunogenicity, and clinical efficacy. The glycosylation profile must be fully characterized for regulatory submissions and monitored as part of routine quality control.
AMSbiopharma provides comprehensive glycan characterization services at both the released glycan and glycopeptide levels. Released N-glycan analysis by HPLC with fluorescence detection or LC-MS/MS provides quantitative data on glycan composition. Glycopeptide analysis by LC-MS/MS provides site-specific glycosylation information.
Key analytical capabilities:
– Released N-glycan profiling by HPLC with fluorescence detection
– Glycan identification and relative quantification by LC-MS/MS
– Site-specific glycosylation analysis through glycopeptide mapping
– O-glycosylation characterization for relevant biological classes
– Applicable to mAbs, Fc fusion proteins, therapeutic enzymes, and biosimilars
– Validated methods for CMC submissions and routine quality control
Drug–Protein Binding Analysis
Characterization of the interaction between a therapeutic molecule and its protein target provides essential information for pharmacological characterization and mechanism of action studies. Quantitative assessment of target engagement provides mechanistic evidence that the drug reaches and binds to its intended target in vivo.
AMSbiopharma provides analytical services for the evaluation of drug–protein engagement, applying mass spectrometry-based approaches to generate quantitative data on drug–target interactions, supporting mechanism of action characterization and structure–activity relationship studies.
Key analytical capabilities:
– Mass spectrometry-based approaches for covalent and non-covalent interactions
– Applicable to diverse therapeutic modalities and target protein classes
– Support for mechanism of action characterization studies
– Analytical support for structure–activity relationship data
– Integration with pharmacodynamic biomarker program design
Protein-Specific Quantification
Accurate and selective quantification of specific proteins in complex biological matrices is a critical analytical requirement in bioanalytical, pharmacodynamic, and quality control applications. The method of choice depends on the context: immunoassay-based approaches provide high sensitivity for low-abundance targets in complex matrices, whereas mass spectrometry-based methods offer greater specificity and multiplexing capabilities.
AMSbiopharma provides validated protein-specific quantification services using ligand-binding assay (LBA) and LC-MS/MS-based approaches. Stable isotope-labelled peptide internal standards ensure accurate and reproducible quantification with appropriate correction for matrix effects.
Key analytical capabilities:
– Validated LC-MS/MS-based protein-specific quantification using stable isotope-labelled standards
– Protein quantification by ligand-binding assay (LBA) for high sensitivity
– Applicable to bioanalytical, pharmacodynamic, and quality control applications
– Protein quantification capabilities
– Applicable to plasma, serum, tissue, and pharmaceutical matrices
