
Pharma
Tentamus Pharma & Med’s GMP laboratories test your pharmaceuticals in accordance with national and international pharmacopoeias.
Our GMP laboratories test pharmaceuticals using the appropriate methods in accordance with national and international pharmacopoeias or validated client methods. We test starting materials, in-process products, active substances and sterile and non-sterile pharmaceuticals using state-of-the-art technology and applying physico-chemical, micro and molecular biological as well as cell culture methods.
Method development and validation
for pharmaceutical analytics
As a pharmaceutical contract laboratory, our work is usually governed by the standardised regulations of national and international pharmacopoeias. However, special sample specifications or the lack of a standardised testing procedure often require the development of specific testing methods. Equally, changes in pharmaceutical formulations or regulatory provisions could mean that the testing methods for a product need to be adapted.
Method development and validation
We consult closely with our clients to develop and validate efficient and robust analytical methods that ensure reliable testing routines. We maintain this transparent approach when preparing validation plans and reports that enable methods to be validated in accordance with the ICH Q2 (R1) guideline.
Method transfer
We are happy to cooperate with other analytics providers if established methods need to be exchanged between two laboratories. We help plan and coordinate the transfer of specific methods – either to or from us – and are happy to take over project management and transfer documentation duties.
Method verification
We check whether each of our analytical methods is suitable in practice and verify the results in accordance with pharmacopoeial regulations.
GMP laboratory
for tried-and-tested pharmaceutical analytics
Tentamus Pharma & Med’s contract laboratories offer a wide range of pharmaceutical analytics. In addition to GMP-compliant routine analytics such as pharmacopoeial analysis, elemental impurities testing, in vitro analysis for active substance release (dissolution testing), residual solvent testing, nitrosamine analytics, etc., we also develop and validate individual testing methods for products that are not (only) tested according to defined standards.
Physico-chemical analysis
Our services in the field of physico-chemical analysis include testing pharmaceuticals for suspended solids, particle size and colour and determining osmolality and fluid content.
Instrumental analytics
-
Atomic absorption spectrometry (AAS) and atomic emission spectrometry (AES)
using the following techniques: flame, nitrous oxide, graphite furnace, hydride and the corresponding digestion methods: acid digestion and microwave digestion to detect metals
-
Inductively coupled plasma mass spectrometry (ICP-MS)
for trace analysis of heavy metals such as mercury, lead or cadmium
-
Gas chromatography (GC)
with the following detectors: FID, NPD and MSD, e.g. determination of content and purity of pharmaceutical raw materials and finished products, residual solvents, fatty acid composition
-
High-performance liquid chromatography (HPLC)
with the following detectors: UV/VIS, RI, ECD, fluorescence, DAD, e.g. determination of content and purity of pharmaceutical raw materials and finished products, biogenic amines and preservatives
-
Ion chromatography (IC) with conductivity detection
for content determination of various anions and cations
-
UV-VIS spectroscopy
for qualitative and quantitative determinations; especially enzymatics
-
IR absorption spectroscopy
for the spectral recording of liquid and solid substances
-
Thin-layer chromatography (TLC)
using a digital documentation system for the purpose of qualitative determinations and impurity testing
-
Determination of Total organic carbon (TOC)
during purification processes, for example
-
Amino acid analyzer
For the detection of ninhydrin-positive substances (amino acids) and their derivatisation products as well as ammonium by UV detection e.g. for the determination of identity, purity and content
-
Capillary Electrophoresis (CE)
Used for the determination of the chirality of small molecules, Capillary Isoelectric Focusing (CIEF) or Capillary Gel Electrophoresis. For the determination of the purity, identity, and content of proteins (e.g. monoclonal antibodies)

Laboratory specialising in
bioanalytics and molecular biology
Tentamus Pharma & Med has a testing platform for GMP-compliant biomolecule analytics: in addition to standard biochemistry, molecular biology and immunological analytics tests, we offer highly specialised testing of biomolecules and their biological functionality. We support biopharmaceutical manufacturers with all analytical questions – from development and validation through to routine investigation of test samples – as well as with the transfer of analysis methods, if required.
Protein and amino acid analytics
- Protein identity through 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)
- Determination of purity and identity of proteins using electrophoresis (Ph. Eur. 2.2.31, Ph. Eur. 2.2.54) and western blotting
- Determination of protein concentration (Ph. Eur. 2.5.33)
- ELISA establishment and protein detection using commercial ELISA tests
Nucleic acid analytics
- Identity, purity testing and quantification of nucleic acids using conventional and real-time PCRs
- Determination of the residual Host cell DNA (Ph. Eur. 2.6.35)
- Determination for Mycoplasma (Ph. Eur. 2.6.7 using NAT)
- Determination of Minute Mice Virus / Minute virus of mice (MMV / MVM)
- Detection of Vesivirus in e.g. Chinese hamster ovary (CHO) cells
- Detection of Retrovirus (reverse transcriptase activity)
- Real Time Fluorescent Product Enhanced RT Assay (F‑PERT)
Immunological and cell analytics
- Pharmacokinetics and determination of anti-drug antibodies as part of pre-clinical studies (in accordance with ICH M3, EMEA, FDA)
- Cytokine profiling/multiplexing (including with minimal sample quantities < 5 µl)
- Immunomonitoring of cell lines and leukocytes (PBMCs) from whole blood
- Flow cytometry (Ph. Eur. 2.7.24) and ELISA
Funktionelle Bioassays
- Effector cell assays (cytotoxicity, apoptosis, ADCC, CDC)
- Proliferation/reporter gene assays
- In vitro potency assays in various cell lines
- Determination of heparin activity (Ph. Eur. 2.7.5)
Microbiology
for pharmaceutical and biopharmaceutical quality control
As a GMP-certified laboratory, we operate in accordance with current ISO standards and OECD guidelines and are authorised to handle biosafety level 2 microorganisms (human and animal pathogens) and biosafety level 1 GMOs.
Our microbiological department specialises in detecting aerobic and anaerobic bacteria, bacterial viruses (bacteriophages) as well as yeasts and fungi. Our pharmaceutical quality control combines classical microbiological methods with the capabilities of a molecular biological and immunological laboratory, allowing us to prepare informative quantitative and qualitative bioburden assays.
Microbiological in vitro analysis
- Determination of bioburden (Ph. Eur. 2.6.12, ISO 11737 – 1)
- Pyrogen determination:
- Bacterial endotoxin test (Ph. Eur. 2.6.14)
- 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
- Identity, purity and quality testing on microbial cell banks, live biotherapeutic products and therapeutic bacteriophage preparations:
- Detection and identification of adventitious microbial contaminants
- Bacteriophage presence test for monitoring and control of bacteriophage contaminations in bio production
- Viability
- Bacterial strain characterisation
- Genotyping / phenotyping (e.g. RFLP, RADP fingerprinting, phage typing, biochemical identification by API 20E, identification by 16S rDNA or ITS sequencing)
- Plasmid copy number
- Plasmid retention (plasmid stability; percent of host cells retaining the plasmid)
- Verification of consistency of the coding sequence of the expression constructs (PCR and sequencing)
- Bacteriophage analytics
- Determination of genotoxicity (AMES test, OECD TG 471)
- Microbiological testing of cosmetics in accordance with CTFA or ISO standards
- Microbiological examination of non-sterile products: microbial enumeration tests (Ph. Eur. 2.6.12)
- Microbiological examination of non-sterile products: test for specified micro-organisms (Ph. Eur. 2.6.13)
- Microbiological examination of cell-based preparations (Ph. Eur. 2.6.27)
- Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation (Ph. Eur. 2.6.31)
- Determination of bactericidal, fungicidal or yeasticidal activity of antiseptic medicinal products (Ph. Eur. 5.1.11)
- Microbiological monitoring of purified water (Aqua purificata) acc. to Ph. Eur.
In vitro analytics
for pharmaceutical and biopharmaceutical quality control
As a GMP-certified laboratory, we operate in accordance with current ISO standards and OECD guidelines and are authorised to handle biosafety level 2 microorganisms (human and animal pathogens) and biosafety level 1 GMOs.
Our microbiological department specialises in detecting aerobic and anaerobic bacteria, bacterial viruses (bacteriophages) as well as yeasts and fungi. Our pharmaceutical quality control combines classical microbiological methods with the capabilities of a molecular biological and immunological laboratory, allowing us to prepare informative quantitative and qualitative bioburden assays.
Microbiological in vitro analyses (Cell-Based in vitro Adventitious Agent Testing Assays / Viral Safety Testing)
- Adventitious/Extraneous Agents Testing from Master / Working Cell Banks (MCB/WCB) according to Ph. Eur. 2.6.16 / 5.2.3
- Testing over a period of 14 and 28 days
- Detection of low-levels of viral contamination in biological productions
- Combination of production cell line (or related cell lines) with guideline compliant indicator cell lines
- Viral standards covering relevant species
- Adventitious agents qPCR based (e.g.)
- Human respiratory syncytial virus (HRSV) of type A and type B
- Human papilloma virus (HPV)
- Human hepatitis virus (HAV / HBV / HCV)
- Influenza (type A / B / C)
- Coronavirus (SARS-CoV‑2 / 229E / OC43)
- Human Cytomegalovirus (hCMV / HHV‑5)
- Detection of other viruses upon request
- Bacteriophage presence test in bacterial cell banks and fermentation samples (validated for E. coli)
- Detection of virulent bacteriophages that undergo lytic replication cycle
- Detection of temperate bacteriophages that undergo lysogenic replication cycle
- Detection of prophages
- Phage identification and bacteriophage presence tests for species other than E. coli can be developed and validated upon request
- Replication-Competent Virus Testing
- Guideline compliant limits (e.g. > 1 ifu among 3 × 10E10 viral particles for Adenovirus RCA)
- Read out: CPE, ICC or qPCR

Stability storage and
stability testing
Stability testing is used to determine and verify the chemical and physical durability of pharmaceuticals under certain storage conditions at a specific humidity and temperature. Such tests are essential in pharmaceutical development, authorisation and registration in order to define and verify shelf life.
We carry out long-term, short-term and ongoing stability storage of finished pharmaceutical products and active substances in accordance with current ICH guidelines and GMP requirements. Clients engage us to test storage and in-use stability, monitor batches on the market (ongoing stability) and test durability in connection with variations.
After the storage period is completed, our analysts set to work according to the stability testing plan or the client’s specifications. We test all forms used for administering pharmaceuticals – from solid forms such as tablets and capsules and semi-solid forms such as creams and ointments through to liquids.
Standardised processes for reliable stability testing:
- Testing plans that meet regulatory requirements
- Narcotic drugs licence in accordance with Section 3 of the German Narcotic Drugs Act (BtMG)
- Import licence for international projects
- Storage in accordance with ICH conditions
- Coordination, analysis, assessment and reports
- Efficient planning and implementation of ongoing stability tests
Our climate cabinets represent all standardised climate conditions and enable reliable and efficient stability storage.
Standard conditions
- Climatic zone II (25°C/60% RH)
- Intermediate condition, climatic zone IVa (30°C/65% RH)
- Accelerated condition (40°C/75% RH)
Special climatic zones
- Climatic zone IVb, (30°C/75% RH)
Cold and frozen storage
- 2°C to 8°C
- -20°C
Narcotic drug analysis of medicinal cannabis
The use of medicinal cannabis in Germany is subject to the Narcotic Drugs Act (BtMG) and is therefore tightly regulated. Tentamus Pharma & Med holds the necessary narcotic drugs licence from the German Federal Institute for Drugs and Medical Devices (BfArM) and is permitted to perform narcotic drug analyses of medical cannabis.
We conduct pharmacopoeial tests on herbal drugs to determine active substance content and purity and to detect impurities of any kind: our wide range of analysis methods includes detecting foreign matter, establishing the presence of pesticides and heavy metals and carrying out microbiological assessments of bacterial load.
Batch release of your cannabis-based pharmaceuticals
We hold a manufacturing licence in accordance with Section 13 of the German Drugs Act (AMG), which enables our Qualified Persons to monitor pharmaceuticals testing and release products.
Analysis according to German Pharmacopoeia (DAB) “cannabis flos” monograph:
- Identity – macroscopic, microscopic, thin-layer chromatography (2.2.27)
- Purity – foreign matter (2.8.2), loss on drying (2.2.32), cannabinol (HPLC)
- Content determination (HPLC) – (Δ9-tetrahydrocannabinol, Δ9-tetrahydrocannabinolic acid, cannabidiol and cannabidiolic acid)
Analysis according to Ph.Eur. “herbal drugs” monograph:
- Pesticides (2.8.13)
- Heavy metals Cd, Pb, Hg, if necessary As (2.4.27)
- Aflatoxins B1, B2, G1 and G2 (2.8.18)
- Ochratoxin A (2.8.22)
- Microbiological quality (5.1.8 B)
- TAMC, TYMC, bile-tolerant gram-negative bacteria, coli bacteria, Salmonellae
Other testing procedures for cannabis-based pharmaceuticals:
- Terpene-Screening
- Detection of pyrrolizidine alkaloids
QP service for
release analytics and EU retests
We hold a manufacturing licence for the release of pharmaceuticals in accordance with Section 13 (1) of the German Drugs Act (AMG). Upon request, our Qualified Persons (as defined in Directive 2001/83/EG) will certify the completed release testing for reference in accordance with Annex 16 of the EU GMP Guidelines in an officially recognised form.
QP services and release testing
We offer release testing and release analytics with QP certification for active substances, drug batches and products governed by the German Narcotic Drugs Act (BtMG) such as cannabis-based therapeutics.
EU retest
Our release tests and EU retests enable pharmaceuticals manufacturers based outside the EU to obtain an import licence for the EU market.