Antibodies

Since the mid-1980s, Antibodies have been developed as a new class of drugs which show a very high degree of specificity and efficacy. Today, 22 monoclonal antibodies are approved by the FDA and are applied in indications ranging from various cancer types to transplant rejection. The success of monoclonal antibodies lies in their natural ability to specifically bind only to certain targets and the high developability of this class of molecules. Protagen Protein Services (PPS) has excellent technical knowledge and long-standing experience in the detailed characterization of antibodies and antibody products

PPS has excellent technical knowledge and long-standing experience in the detailed characterization of antibodies and antibody products such as:

• Recombinant monoclonal IgG-Type
• Polyclonal IgG
• Fusion proteins
• Fc-constructs
• Fab-fragments
• Β-functional antibodies

Analytical support throughout the whole antibody development

PPS has extensive experience in analysis of different antibody formats and can successfully support you with:

• Developability assessment of candidates
• Detailed Structural Characterization
• Development, Qualification up to Validation of specific analytical methods
• Stability Testing
• Release Testing

PPS provides individual analyses or a comprehensive characterization package customised to suit your requirements and to provide data required by the regulatory authorities for antibody analysis like:

• Determination by intact mass analysis
• Purity and integrity analysis by CE-SDS and cIEF analysis
• Identification by peptide mapping mass spectrometry
• Assessment of quantity by amino acid analysis and liquid chromatography (HIC, RP-HPLC, IEX)
• Aggregation analysis by SEC-MALLS and Analytical Ultracentrifugation (AUC)
• Glycosylation analysis by mass spectrometry, HILIC-FL and HPAEC-PAD
• Mass spectrometric assessment of free thiol groups and disulfide bridges
• Determination of molar extinction coefficient
• Specific functional and potency assays on request

PPS provides a strategic approach for characterizing biopharmaceutical products. Analysis is performed in a GMP compliant laboratory using validated techniques to satisfy the latest regulatory requirements.

Structural characterization and confirmation

Process and product related impurities