GLP / GMP certified
contract laboratory
supporting all phases of biological drug development
Analytics of biologics - tailored to your needs
- According to national and international guidelines
- Analytic of pre-clinical and clinical trial specimen up to Phase III
- Characterization and QC testing of biomolecules from early stages of development until QP release
- ICH compliant long-term, intermediate and accelerated stability studies GMP compliant sample storage from room temperature to -196 °C
Our Portfolio
Our analytical portfolio as a contract laboratory offers services for biologics (ATMPs, biopharmaceuticals, originator products, biosimilar candidates, biosimilars, blood and blood components, vaccines), chemicals and excipients from early stages of product development (non-clinical, clinical) until market release testing for pharma and biotech companies.
We are GLP certified, GMP certified and GCLP-compliant.
Our solution-oriented and flexible approach allows us to analyze your products in the fields of physico-chemical analysis, ligand binding assays, cell based assays and microbiology. For more detailed information of our services follow the link below.
- Luminescence, Fluorescence & Absorbance technologies
- Cell-based assays
- Reporter gene & Cytotoxicity assays
- Mode of Action
- mRNA expression
- Ligand Binding Assays
- ELISA
- Electrochemiluminescence
- Surface Plasmon Resonance (SPR)
- PCR & qPCR
- Biocomparability studies
- Content determination and identity testing
- High-Performance Liquid Chromatography (HPLC)
- Capillary Electrophoresis (CE, CE-SDS, cIEF)
- Electrophoretic methods
- Advanced physicochemical characterization
- Bioburden testing
- Sterility verification
- Endotoxin testing
- Gel clot
- rFc
- LAL
- Total Organic Carbon (TOC)
- Microbiological quality control
- Routine cell banking
- Cell bank analytics
- Characterization and safety testing
- Anti-Drug Antibody (ADA) testing
- Pharmacokinetics (PK) & Pharmacodynamics (PD)
- Biomarker analysis
- PBMC isolation & storage
- ICH-compliant stability studies
- Long-term, intermediate & accelerated programs from room temperature to -196 °C
- Shipment coordination & Sample logistics
- GMP batch release testing including QP release
- Customer-specific batch release analytics
- Stability studies
- Method transfer & validation
- Pharmacopoeia compliant testing
- Quality management & Audit support
- Consulting services
- LC-MS & GC-MS
- MALDI-TOF germ identification
- Glide force testing
- T-cell assays
- In-vitro toxicology
- Bacteriophage testing
- Monocyte Activation Test (MAT)
- ISO-17025 compliant services
Find our partner laboratories here:
Contract laboratory for pharmaceuticals and medical devices | Tentamus Pharma & Med
Also check out our Cooperations & Memberships
Have a look at our company and find out which services we offer!
