Biosynth GmbH has established a comprehensive set of analytical methods for the characterization of bioconjugates and chemical polymers that are used as active pharmaceutical ingredients (APIs) or excipients in pharmaceutical preparations.
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Our currently available methods include:
Parameter | Method | Bioconjugate | Polymer | GMP |
---|---|---|---|---|
Product characterization | ||||
Absolute MW, polymer : protein ratio | SEC-UV-RI-MALLS | ✓ | ✓ | |
MW, PDI, purity, content | SEC-RI / GPC-RI | ✓ | ✓ | ✓ |
Absolute MW, degree of modification | MALDI-ToF-MS, LC-ESI-MS | ✓ | ✓ | ✓ |
Structural integrity | NMR | ✓ | ✓ | ✓ |
Potency, enzymatic activity | Colorimetric assays, UV-VIS methods in well-plate format | ✓ | ✓ | |
Identity, PTMs, PEGylation sites | LC-MS-based peptide mapping | ✓ | ||
Extinction coefficient | Amino acid analysis | ✓ | ✓ | |
Content and concentration | UV/VIS spectroscopy, BCA assay, chromatographic methods | ✓ | ✓ | |
Terminal activity | RP-HPLC | ✓ | ✓ | |
Product related impurities / degradation products | ||||
Purity, Identity, structural integrity | SDS-PAGE followed by – Coomassie staining – Titrisol staining – Western-Blotting | ✓ ✓ ✓ | ✓ ✓ | ✓ ✓ ✓ |
Identity | ELISA | ✓ | ||
Purity, impurity profile | SE-LC & HPLC, UPLC | ✓ | ✓ | ✓ |
Isoforms, oxidated / deaminated species, aggregates | UPLC/HPLC in combination with RP, SEC or IEX methodology | ✓ | ✓ | |
Process related impurities or additives | ||||
BHT | RP-UPLC | ✓ | ✓ | ✓ |
Cyanide | Colorimetric assay | ✓ | ✓ | ✓ |
NHS | RP-HPLC | ✓ | ✓ | ✓ |
PEG | RP-UPLC/HPLC with ELS or CA detection | ✓ | ✓ | ✓ |
Polymers in protein solutions | SE-UPLC-ELSD, RP-UPLC-ELSD | ✓ | ||
Polysorbate 20 / 80 | RP-HPLC-ELSD or CAD | ✓ | ||
Bioanalytics (in biological samples) | ||||
Anti-drug antibodies | ELISA / Western blotting | ✓ | ||
Amino acid levels | RP-HPLC with pre-column derivatization | ✓ | ||
Bioconjugate level | ELISA, HPLC | ✓ | ||
Degradation products | Western blotting, HPLC | ✓ | ✓ | |
General and generic methods | ||||
Conductivity and pH | Conductometry, potentiometry | ✓ | ✓ | ✓ |
Osmolality | Freeze point osmometry | ✓ | ✓ | ✓ |
Appearance, color, clarity | Visual inspection | ✓ | ✓ | ✓ |
Turbidity | Nephelometry | ✓ | ✓ | ✓ |
Water content | Karl-Fischer titration | ✓ | ✓ |
Biosynth GmbH is constantly extending its analytical methods portfolio. If your analytical need is not listed above, we are happy to develop a new method specifically for your purpose.
Contact partner
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Dr. Wolfram Lorenzen
Head of QC
+49 30 9489 2350