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Bioanalytics

Our divsion of bioanalytics combines our expertise in biochemistry, molecular biology, tissue culture and immune analytics. We offer, besides standard technologies, a specialized platform for testing biomolecules and their biological effects.

Nucleic Acid Analytics

  • Identity and purity testing of nucleic acids by PCR-based technologies and electrophoresis
  • Copy number determination by Real-Time PCR

Protein/Peptide Analytics

  • Protein purity and identity testing by electrophoretic techniques (Ph. Eur. 2.2.31, Ph. Eur. 2.2.54) and Western-Blot
  • Protein Identity by 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)
  • Determination of protein concentration (Ph. Eur. 2.5.33)
  • ELISA techniques

Immune- and Cell Analytics

  • Performance of analyte specific stability and proof of unwanted immunogenicity: PK/ADA studies (according to ICH M3, EMEA, FDA)
  • Cytokine profiling (also with minimal sample amount < 5 ┬Ál)
  • Multiplexing technologies: AYOXXA Lunaris and Mesoscale MSD)
  • Immunoprofiling of PBMCS
  • Enzyme-linked immunosorbent assays (ELISA)
  • Flow Cytometry (Ph. Eur. 2.7.24)

Cell culture based Bioassays

  • Performance of analyte specific cell effector assays (Apoptosis, ADCC, CDC)
  • Proliferation/Reporter gene assays
  • Implementation and performance of analyte specific in-vitro potency assays
  • Assay of Heparin (Ph. Eur. 2.7.5)

TentaMedix offers a diverse platform for the GMP compliant analytics of biomolecules from standard techniques to the custom made bioassay. We support you in analytical method development and method validation/verification as well as in the routine analytics of your test item.

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