Protein and Biologics Characterization/ NO GMP

Integrated multi-attribute analytical characterization services for innovative biologics and complex therapeutic proteins

The analytical characterization of biologics—including monoclonal antibodies, bispecific antibodies, Fc fusion proteins, enzyme replacement therapies, coagulation factors, cytokines, and other protein therapeutics—represents one of the most complex analytical challenges in pharmaceutical development. The inherent structural heterogeneity of these molecules, arising from post-translational modifications (PTMs), charge and size variants, and glycosylation heterogeneity, means that no single analytical technique can provide a comprehensive assessment of their critical quality attributes (CQAs).

A comprehensive characterization strategy requires the application of multiple orthogonal analytical techniques, with the combined dataset providing the complete quality profile expected by regulatory authorities.

AMSbiopharma offers integrated characterization services supported by a comprehensive analytical portfolio covering primary structure confirmation, higher-order structure (HOS) assessment, glycosylation characterization, charge and size variant profiling, aggregate analysis, purity determination, and functional activity testing.

Our catalog of services include

Metabolomics applications

Analysis and Characterization of Novel Proteins and Monoclonal Antibodies (mAbs)

Novel protein therapeutics and monoclonal antibodies (mAbs) require a multi-attribute characterization strategy that addresses every molecular quality attribute relevant to clinical safety, efficacy, and regulatory approval.

AMSbiopharma provides integrated characterization services using a comprehensive panel of orthogonal analytical techniques. Primary structure is confirmed by LC-MS/MS peptide mapping; molecular mass and isoform distribution are characterised by intact and middle-up mass spectrometry; glycosylation is profiled through released glycan analysis and glycopeptide mapping; and charge heterogeneity is assessed using ion-exchange chromatography (IEX).

Key analytical capabilities

  • Sequence confirmation and post-translational modification (PTM) mapping by LC-MS/MS peptide mapping 
  • Intact and middle-up mass spectrometry for molecular mass determination and isoform characterization 
  • Glycosylation profiling by released glycan analysis and glycopeptide mapping 
  • Multi-Attribute Method (MAM) approaches for comprehensive quality attribute monitoring

Monoclonal antibodies (mAbs) require rigorous characterization across multiple structural levels to demonstrate product quality. EMA and FDA guidelines clearly define expectations for the breadth and depth of mAb characterization, encompassing primary structure, higher-order structure (HOS), post-translational modifications (PTMs), purity, aggregation, charge heterogeneity, and functional activity.

AMSbiopharma provides comprehensive mAb characterization services using validated orthogonal analytical techniques to generate a complete molecular characterization package, from primary sequence confirmation and glycoform profiling to the assessment of aggregation state, Fc and Fab structural integrity, and binding activity.

Key analytical capabilities

  • Primary structure confirmation and sequence integrity assessment by LC-MS/MS peptide mapping 
  • Glycoform profiling and site-specific glycosylation characterization 
  • Charge and size variant profiling using multiple orthogonal analytical methods 
  • Aggregate and subvisible particle analysis

Interferons, insulins, and coagulation factors are well-established protein therapeutics with mature regulatory frameworks and stringent analytical requirements defined in pharmacopoeial monographs and product-specific regulatory guidance.

AMSbiopharma provides validated analytical characterization services for these biologics, employing methods aligned with applicable pharmacopoeial monographs, ICH guidelines, and regulatory expectations. Our analytical capabilities include identity confirmation, purity assessment, potency determination, and structural integrity evaluation to support product development, quality control, and regulatory submissions.

Key analytical capabilities

  • Identity confirmation and structural characterization 
  • Purity assessment using HPLC, capillary electrophoresis (CE), and electrophoretic techniques

Toxin-based therapeutics require specialised analytical expertise for the characterization and quality control of highly potent molecules with complex structural attributes.

AMSbiopharma has extensive experience in the analytical characterization of therapeutics derived from natural, recombinant, and novel toxins, applying validated methods for identity confirmation, purity and impurity profiling, potency assessment, and structural integrity evaluation.

Key analytical capabilities

  • Identity confirmation and structural characterization by mass spectrometry 
  • Purity and impurity profiling to support regulatory submissions 
  • Applicable to immunotoxins, bacterial toxins, and toxin-derived conjugates

Antibody–drug conjugates (ADCs) combine the target specificity of monoclonal antibodies with the cytotoxic potency of small-molecule payloads, creating therapeutics of exceptional structural and analytical complexity. The quality of an ADC is determined by attributes such as the drug-to-antibody ratio (DAR), conjugation site distribution, the proportion of unconjugated antibody, free payload, and the presence of aggregates.

AMSbiopharma provides comprehensive ADC characterization services addressing both the antibody and payload components. Our analytical capabilities include DAR determination, conjugation site mapping by LC-MS/MS peptide mapping, free payload quantification, aggregation profiling, and stability assessment.

Key analytical capabilities

  • Drug-to-antibody ratio (DAR) determination using multiple analytical approaches 
  • Conjugation site analysis and mapping by LC-MS/MS peptide mapping 
  • Integrated characterization of both antibody and payload quality attributes

Heparins and glycosaminoglycans (GAGs) are structurally complex, highly sulfated polysaccharide therapeutics that require specialised analytical approaches. The inherent microheterogeneity of these polydisperse molecules, together with their complex charge density, makes their analytical characterization particularly challenging.

AMSbiopharma provides validated analytical services for the characterization and quality control of unfractionated heparin (UFH) and low-molecular-weight heparins (LMWHs), covering molecular weight distribution, anticoagulant potency determination, structural characterization, and impurity profiling, including the detection of oversulfated chondroitin sulfate (OSCS).

Key analytical capabilities

  • Molecular weight distribution analysis by size-exclusion chromatography (SEC) or polyacrylamide gel electrophoresis (PAGE) 
  • Anticoagulant potency determination using validated chromogenic assays 
  • Structural characterization by disaccharide composition analysis 
  • Detection of OSCS and other adulterants for safety assessment 
  • Impurity profiling in accordance with Ph. Eur. and USP requirements 
  • Applicable to UFH, LMWHs, and novel glycosaminoglycans

Bispecific antibodies (bsAbs) present analytical characterization challenges that extend well beyond those of conventional monoclonal antibodies (mAbs). The complexity of bispecific antibody formats requires analytical strategies specifically designed to address the unique quality attributes of each molecular architecture, including confirmation of correct heterodimer assembly and quantification of mispaired species.

AMSbiopharma provides tailored characterization services for bispecific antibodies, applying orthogonal analytical techniques to assess heterodimer purity, dual-target binding specificity, charge and size heterogeneity, glycosylation, and aggregation.

Key analytical capabilities

  • Quantification of heterodimer purity and homodimer-related impurities 
  • Confirmation of dual-target binding specificity 
  • Charge and size variant profiling tailored to bispecific antibody architectures 
  • Glycosylation characterization for Fc-asymmetric bispecific antibodies 
  • Assessment of aggregation and higher-order structure (HOS)