Bioanalytics
Tentamus Pharma & Med has a testing platform for GMP-compliant biomolecule analytics.
In addition to standard tests in biochemistry, molecular biology and immunoanalytics, we provide highly specialised testing of biomolecules and their biological functionality. We support manufacturers of biopharmaceuticals in all analytical issues from development to validation to routine testing of test samples - and also in the transfer of analytical methods if required.
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)