Bioanalytics

Besides standard technologies we offer 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 and Amino Acid Analytics

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

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 µl)
• 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.