Protagen AG has excellent technical knowledge and long-standing experience in the detailed characterization of antibodies and antibody products such as:
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Protagen AG provides individual analyses or a comprehensive characterization package customised to suit your requirements and to provide data required by the regulatory authorities.
Protagen AG 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.
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Guideline requires |
Protagen AG Offers |
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Structural characterization and confirmation |
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Amino acid sequence |
✔ |
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Amino acid composition |
✔ |
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N- & C-terminal sequencing |
✔ |
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Peptide mapping |
✔ |
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S-S bridge analysis |
✔ |
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Glycosylation analysis |
✔ |
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Physicochemical properties |
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Molecular weight or size |
✔ |
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Isoform pattern |
✔ |
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Extinction coefficient |
✔ |
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Electrophoretic patterns |
✔ |
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Liquid chromatographic patterns |
✔ |
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Spectroscopic profiles |
Via Partner |
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Process and product related impurities |
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Host cell proteins |
✔ |
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Truncated forms |
✔ |
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Post-translational modifications (PTM) |
✔ |
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Aggregates |
✔ |
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Dr Katja AschermannHead of Business Development Protein Services. Phone: +49 (0) 231 9742-6300 |