Laboratory specialising in
bioanalytics and molecular biology

Proteins & Amino Acids

  • Protein identity by determination of amino acid composition (ninhydrin positive substances, Ph. Eur. 2.2.56)
  • Amino acid analysis of raw materials (Ninhydrin positive substances, Ph. Eur. 2.2.56)
  • Capillary electrophoresis: Determination of purity, identity and content of proteins, e.g. monoclonal antibodies.
  • Determination of purity and identity of proteins by electrophoresis (Ph. Eur. 2.2.31 and 2.2.54) and Western blot
  • Determination of protein concentration (Ph. Eur. 2.5.33)
  • ELISA establishment and protein detection using commercial ELISA tests

Nucleic acids

  • Identity, purity testing and quantification of nucleic acids by conventional and quantitative real-time PCR
  • Detection of residual host cell DNA (Ph. Eur. 2.6.35)
  • Determination for Mycoplasma (Ph. Eur. 2.6.7 using NAT)
  • Determination of viral contamination including Minute virus of mice (MMV / MVM) and Vesivirus
  • Detection of retroviruses (reverse transcriptase activity) and Real Time Fluorescent Product Enhanced RT Assay (F-PERT)

Immune and cell analysis

  • Cultivation and storage of cell lines and PBMCs under standardised conditions
  • Cell analysis by flow cytometry (Ph. Eur. 2.7.24)
  • Preparation and characterisation of leukocytes (PBMCs) from human and animal blood (immune profiling)
  • Detection of immunologically relevant markers and cytokines using different technologies (immune monitoring)
  • Monocyte activation test (Ph. Eur. 2.6.30)
  • ELISA implementation, qualification and analysis
  • Stability testing of analytes in matrices (pharmacokinetic studies)
  • Detection of unintentional immunogenicity / Anti Drug Antibodies

Functional bioassays

  • Performance of cell effector assays (cytotoxicity, apoptosis, ADCC, CDC)
  • Proliferation/Reporter Gene Assays
  • Implementation and performance of in vitro potency assays in different cell lines
  • Heparin activity determination (Ph. Eur. 2.7.5)
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