Dr. Marcus Mreyen
Head of Business DevelopmentCentral Europe
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:
Analytical support throughout the whole antibody development
PPS has extensive experience in analysis of different antibody formats and can successfully support you with:
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:
Protagen Protein Services (PPS) has extensive experience in analysis of different protein classes and other formates and can successfully support you with a broad range of services:
Read more to the individual analytical services here
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
Guideline requires | Protagen Protein Services (PPS) Offers |
Amino acid sequence | ✔ |
Amino acid composition | ✔ |
N- & C-terminal sequencing | ✔ |
Peptide mapping | ✔ |
S-S bridge analysis | ✔ |
Glycosylation analysis | ✔ |
Physicochemical properties
Guideline requires | Protagen Protein Services (PPS) Offers |
Molecular weight or size | ✔ |
Isoform pattern | ✔ |
Extinction coefficient | ✔ |
Electrophoretic patterns | ✔ |
Liquid chromatographic patterns | ✔ |
Spectroscopic profiles | ✔ |
Process and product related impurities
Guideline requires | Protagen Protein Services (PPS) Offers |
Host cell proteins | ✔ |
Truncated forms | ✔ |
Post-translational modifications (PTM) | ✔ |
Aggregates | ✔ |