Analytics from Biopharm

The services we offer range from method development and validation to taking on the complete responsibility for release, stability and comparability testing.
Analytical testing of drugs and active substances and developmental work are performed in accordance with GMP (EU Directive 91/356/EEC Good Manufacturing Practice for Medicinal Products Intended for Use in Man; ICH Q7A for active substances) or GLP (Appendix 1 to ChemG § 19 a of 8 May 2001).

Download: Analytical Services (1,2 MB)

Our methods include:

Protein analytics

Chromatography (SEC, IEC, RP-HPLC) Peptide mapping Electrophoresis (SDS PAGE, IEF) Western blot Amino acid sequencing Protein sequencing (N- and C-terminal) Spectroscopy (UV-VIS, fluorescence, IR) Protein content (CBB, BCA, UV) Mass spectrometry (MALDI TOF MS) Determination of sialic acid ELISA

Organoleptic tests

Visible particles Opalescence Color

Physical and physicochemical tests

Optical rotation Melting point Residual moisture Spectroscopy (IR, UV-VIS, fluorescence) Osmolality Thin layer chromatography Limit tests Loss on drying

Dissolution testing

Spectroscopy Chromatography

Residual DNA analysis

prokaryotic-genomic DNA

Silicone oil determination

Extraction followed by IR spectroscopy

GLP-analytics and testing of clinical samples

Determination of the drug in sera Quantification of anti-antibodies Quantification of neutralizting antibodies

Unlabeled binding studies

Surface plasmon resonance (Biacore)