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.