Bio­ana­lytics

With modern instrumental methods of analysis, we support our research partners from the pharmaceutical, biotechnology and medical technology in the development, evaluation and QC of their products.

We are looking for biomarkers for identify degradation products, measured release kinetics...

we analyze

  • proteins and conjugates
  • glycoproteins
  • peptides, lipids, oligosaccharides, RNA, DNA, metabolites ..
  • polymers,...

Services

Analytical services are tailored to the needs of our customers and performed within the quality control system of the NMI. Analysis procedures can be validated according to the regulations for accredited test laboratories (DIN-EN-ISO-17025). If necessary, accreditation of these new test methods is also possible. Some analytical methods can also be developed for use under GMP conditions. These methods can be transferred to the GMP laboratory of the NMI TT GmbH and used for quality controls, stability tests or release analyses of products for clinical applications.


Techniques, methods

Depending on the task, modern bioanalytical methods are used to achieve optimum results in terms of efficiency, costs and throughput. The method panel comprises chromatographic and electrophoretic separation methods, which are coupled with various detection methods.

Method panel for biomolecules:

  • Amino acids: identification of unusual amino acids / ageing and stress markers
  • Peptide analytics QC, aging, peptides as biomarkers
  • Recombinant proteins: QC, ageing, glycosylation Link to pdf with method description
  • Lipid analytics : lipid composition, lipid metabolites
  • Oligonucleotides: siRNA QC, release, degradation behavior
  • Metabolites: Phytopharmaceuticals, Identification, Quantification

Method Panel for Synthetic Agents:

  • Quantification of Pharmaceuticals: Drug Eluting Stents - Release Kinetics
  • Identification & Quantification of chemical additives and impurities

Method Panel for Polymers

  • MALDI TOF Analysis of polymers and degradation products
  • GPC analysis of polymers, intrinsic viscosity, hydrodynamic radius, molecular weight
  • Viscosity of polymer solutions, hydrogels

Equipment

Mass spectrometer:

  • ESI-UHRTOF Mass Spectrometer (MAXIS, Bruker)
  • ESI Triple Quadrupole Mass Spectrometer - (API3000, AB Sciex / Quattro Micro, Waters)
  • MALDI-TOF-TOF mass spectrometer (Ultraflex III, Bruker)

Chromatography systems:

  • UPLC (RSLC Ultimate 3000, Dionex)
  • nanoHPLC (Easy nanoLC, Proxeon )
  • HP 1100 + Fluorescence / ELSD / UV detectors
  • Biochromatography system (Äkta Explorer, GE Healthcare)
  • HPSEC with tetra detection (UV / LALS / RALS, RI / viscometer) (GPCmax+TDA350, Malvern)

Electrophoresis:

  • 1D / 2D -SDS-PAGE, Western Blot

Networks

Clinics/universities: Tübingen, Freiburg, Kiel, Berlin, Reutlingen, Albstadt-Sigmaringen