Peptide and Amino Acid Analysis / Non-GLP

Validated analytical services for therapeutic peptides, amino acids, and synthetic peptide-based therapeutics across all stages of development.

Therapeutic peptides represent one of the fastest-growing segments of the biopharmaceutical pipeline. Encompassing innovative peptide new chemical entities (NCEs), generic versions of established peptide drugs, cyclic and modified peptides with enhanced stability profiles, and hybrid peptide molecules, this diverse class requires analytical approaches that bridge the disciplines of small-molecule pharmaceutical chemistry and biologics.

The analytical characterization of therapeutic peptides requires validated methods capable of confirming sequence integrity, assessing purity against synthetic impurities and degradation products, characterising physicochemical properties, and detecting post-synthetic modifications relevant to product quality.

AMSbiopharma provides comprehensive analytical services for therapeutic peptides and amino acid-based therapeutics across all stages of development, from early-stage characterization to complete CMC analytical packages for regulatory submissions.

Protein-based pharmaceutical products require specialized analysis to ensure their quality and efficacy.
AMSbiopharma offers advanced analysis services for TIDES (Oligonucleotide and Peptide Therapeutics), tailored to the specific needs of the pharmaceutical and biopharmaceutical industries, focusing on drug quality control and ensuring compliance with regulatory standards.
AMSbiopharma collaborates with industry experts and utilizes cutting-edge technologies to provide in-depth protein analysis services, supporting clients in optimizing their protein-based pharmaceutical products for market success.

Our catalog of services include

Metabolomics applications

Therapeutic Peptide Analysis and Characterization (Innovative, Generic and Hybrid Peptides)

Comprehensive analytical characterization of therapeutic peptides requires a multi-method approach covering primary structure, sequence integrity, purity, related substances, and physicochemical properties. For generic peptide products, the analytical programme must also address analytical comparability with the reference product.

AMSbiopharma provides characterization services for therapeutic peptides. Primary structure and sequence integrity are confirmed using mass spectrometry, with high-resolution intact mass analysis and peptide mapping providing comprehensive molecular characterization.

Key analytical capabilities

  • Sequence confirmation and integrity assessment by high-resolution intact mass analysis and peptide mapping 
  • Purity and related substances profiling using HPLC methods 
  • Structural characterization of cyclic, modified, and conjugated peptides 
  • Applicable to linear peptides, cyclic peptides, disulfide-bonded peptides, and backbone-modified peptides

Amino acid analysis provides essential compositional information for the identity confirmation and quality control of proteins, peptides, and amino acid-based pharmaceuticals. Amino acid composition serves as an identity test, a tool for protein content estimation, and a quantitative quality control assay for formulated products.

AMSbiopharma provides validated analytical services for the quantification of amino acids and related compounds in drug substances, drug products, and biological matrices, applying validated hydrolysis and derivatisation protocols followed by chromatographic separation and detection.

Key analytical capabilities

  • Amino acid composition analysis for protein and peptide identity confirmation 
  • Quantification of all proteinogenic amino acids 
  • Applicable to drug substance characterization and quality control 
  • Support for protein content estimation by amino acid analysis 
  • Applicable to drug substances, drug products, and biological matrices 
  • Complete validation documentation for regulatory submissions

Peptide mapping is one of the most powerful and informative analytical characterization techniques for protein and peptide therapeutics. By enzymatically digesting the protein into defined peptide fragments and analysing the resulting mixture by LC-MS/MS, peptide mapping provides comprehensive sequence coverage, confirms primary structure integrity, and detects post-translational modifications (PTMs) and chemical degradation at the molecular level.

AMSbiopharma provides validated peptide mapping services using optimised digestion protocols and LC-MS/MS analysis, delivering high sequence coverage together with confident identification and localisation of post-translational modifications, including glycosylation, oxidation, deamidation, phosphorylation, and disulfide bond assignment.

Key analytical capabilities

  • LC-MS/MS-based peptide mapping with high sequence coverage 
  • Identification and localisation of post-translational modifications 
  • Glycosylation site mapping and glycopeptide characterization 
  • Disulfide bond mapping and free cysteine determination 
  • Monitoring of deamidation, oxidation, and other chemical degradation products

Accurate and sensitive quantification of synthetic therapeutic peptides in complex biological matrices is a specialised bioanalytical requirement for PK/PD studies and clinical pharmacology programmes. The structural similarity of peptide therapeutics to endogenous peptides, combined with their susceptibility to enzymatic degradation, requires carefully developed analytical methods to ensure sensitivity, selectivity, and stability.

AMSbiopharma provides LC-MS/MS bioanalytical services for the detection and quantification of synthetic therapeutic peptides in plasma, serum, urine, and other biological matrices, with full method validation in accordance with ICH M10.

Key analytical capabilities

  • LC-MS/MS methods for the quantification of synthetic peptides in biological matrices 
  • Method development addressing peptide stability, sample extraction, and analytical sensitivity 
  • Applicable to plasma, serum, urine, and other biological matrices