Protein Identification & Characterization Services

Structural, Physicochemical and Biophysical Characterization Methods

At BioPharmaSpec, we understand the importance of protein characterization during the development and production of your biologic. With our experienced team and cutting-edge analytical methods, we offer tailored solutions to propel your molecule to success. Whether you're working on a new molecule, biosimilar, peptide, antibody, or any other type of biopharmaceutical, BioPharmaSpec is your trusted partner.

Our comprehensive range of analytical services meets global regulatory requirements for biopharmaceutical characterization. With our commitment to quality and technical expertise, you can be sure that your characterization project will be completed accurately, on time and within budget.

Our Protein Characterization Techniques

At BioPharmaSpec, we utilize a variety of advanced techniques to characterize (glyco)proteins accurately and comprehensively. Our methods include:

  • Mass spectrometry-based protein identification: Utilize advanced MS-based protein identification techniques to analyze your product or impurities in your sample, providing valuable insight into composition and structure.
  • Peptide Mapping: Employ powerful LC/ES-MS, Q-TOF for precise separation and identification of peptides, revealing the protein's complete sequence, including amino acid composition and surrounding microenvironment, including disulfide linkages.
  • Disulfide Bridge Assessment: Determine the presence of disulfide bridges within your protein through detailed peptide mapping methods.
  • Charge Isoform Analysis: Assess the charge isoforms of your protein using icIEF for detailed characterization.
  • And many more techniques for Post Translational Modification (PTM) analysis, tailored to meet your specific characterization needs.

Comprehensive Protein Analysis Services

Purity and Impurities

Host Cell Protein (HCP) Analysis & Detection

BioPharmaSpec has developed a service for MS based HCP detection and quantitation as an orthogonal support to HCP-ELISA.

Process Related Impurities

BioPharmaSpec provides methods for the analysis of a significant range of process related impurities. These methods have been developed to allow identification and quantitation to low ppm/ppb limits.

Advanced Functional Testing by our partner, Custom Biologics

Streamlined Analytical Process

Our Protein Characterization Methods

Amino Acid Analysis Triplicate hydrolysis, duplicate injection
N-terminal Sequencing 15 cycles of Edman degradation (light and heavy chains as appropriate)
C-terminal sequencing Determined through molecular weight and peptide mapping
Peptide Mapping Multiple digestion strategies and LC/ES-MS, Q-TOF
Glycosylation site occupancy Determined through peptide mapping and glycan analysis
Primary sequence confirmation MS based sequencing and Ile/Leu differentiation using Edman for the full sequence
Disulfide Bridge Assessment Determined through peptide mapping
Monosaccharide Composition Analysis Neutral and amino sugars

Sialic acids
Oligosaccharide profiling HILIC analysis of 2-AB labelled oligosaccharides covering the analysis of total N-glycans

Linkage (methylation) analysis
Intact molecular weight analysis As received, following reduction, following de-N-glycosylation, following reduction and de-N-glycosylation.

On line RP-HPLC-MS
icIEF With and without Carboxypeptidase B treatment
CE-SDS Non reducing and reducing
RP-HPLC with UV detection Performed on the sample as received
Ion Exchange Chromatography Isoforms can be collected and characterized
DSC To assess melting temperature
CD For far-UV (for secondary structure) and near UV (for tertiary structure)
FT-IR Secondary structure
IF Secondary and tertiary structure
1D and 2D NMR Secondary and tertiary structure
SEC-MALS Aggregation assessment
SV-AUC Orthogonal aggregation assessment
Cell based assay(s) Functional assessment
Binding assay(s) Assessment of binding affinity to receptors, ligands etc

Ready to Maximize Your Protein's Potential?