TentaMedix is a biotechnology company that offers advanced bioanalytical and microbiological services for pharmaceutical, medical and biotechnology companies under GMP or non-GMP. The company is equipped with state-of-the-art analytical equipment and an experienced team of experts divided into 3 main analytical departments; microbiology, bioanalytics, and biocompatibility/ biological safety.
The following is a list of the broad spectrum of services offered by TentaMedix:
Microbiology
Combining classical microbiology like detection, enrichment, isolation, and identification according to official guidelines with the potential of a molecular biological and immunological testing facility. Testing of raw materials, pharmaceutical products, bacterial cell banks, cosmetics, medical devices, and samples from preclinical trials.
- Determination of Bioburden ( Ph. Eur. 2.6.12, ISO 11737-1)
- Pyrogen determination:
- Bacterial Endotoxin (LAL) Test (Ph. Eur. 2.6.14; Ph. Eur. 5.1.10)
- Monocyte Activation Test (Ph. Eur. 2.6.30)
- Microbiological examination of live biotherapeutic products (Ph. Eur. 2.6.36, Ph. Eur. 2.6.38)
- Purity testing of bacterial cell banks
- Bacteriophage analytics
- Determination of Genotoxicity (AMES Test, OECD TG 471)
- Microbiological testing of cosmetics according to CTFA or ISO standards
Bioanalytics
Besides standard technologies, the company offers a specialized platform for testing biomolecules and their biological effects.
- Nucleic Acid Analytics
- Protein and Amino Acid Analytics
- Immune- and Cell Analytics
- Cell culture-based Bioassays
Biocompatibility / Biological Safety
A highly sophisticated and accredited in-vitro platform for testing medical devices according to the DIN ISO 10993. The company is skilled to test pharmaceuticals and biologically active substances using cellular test systems according to internationally accepted guidelines.
- Determination of cytotoxicity in-vitro
- Skin irritation and sensitization in vitro
- Occular corrosion and irritation
- Genotoxicity
- Hemocompatibility
- Pyrogen Testing
- Bioburden and Sterility
- Chemical characterization
- Biocompatibility in-vivo