Bioanalytics

Our divsion of bioanalytics combines our expertise in biochemistry, molecular biology, as well as cell- and immune-biology. We offer, besides standard techniques, a specialized platform for testing biomolecules and their biological effects.

Nucleic Acid Analytics

• Identity and purity testing of nucleic acids by standard electrophoretic, PCR-based, spectroscopic and/or staining techniques
• Copy number determination of your target 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 AA 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) and ELISA techniques

Immune- and Cell Analytics

• Performance of analyte specific stability and proof of unwanted immunogenicity / PK-STUDIES (according to ICH M3, EMEA, FDA)
  
• Cytokine profiling (minimal sample amount and multiplexing)
• Immunoprofiling of PBMCS
• Enzyme-linked immunosorbent assays (ELISA)
• Flow Cytometry (Ph. Eur. 2.7.24)

Cell culture based bioassays and potency assays

• 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 you a diverse platform for the GMP compliant analytics of your biomolecule. From standard techniques to custom made bioassays. We support you on analytical method development, analytical method validation/verification/transfer, and on routine analysis of your test items.