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.
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
Dr. Wolfram Lorenzen
Head of QC
+49 30 9489 2350