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.

The demanding task of devel­oping a scien­tif­i­cally reli­able and econom­i­cally viable testing method is in safe hands with the expe­ri­enced analysts at Tentamus Pharma & Med Deutschland.

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)

pharma&med pharma methoden entwicklung Labor

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.

We use micro­bi­o­log­ical in vitro analysis to perform quality control for biophar­ma­ceu­ti­cals and other phar­ma­ceu­ti­cals and to test raw mate­rials, phar­ma­ceu­tical prod­ucts and bacte­rial cell banks for micro­bial impu­ri­ties and residues.

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.

We use micro­bi­o­log­ical in vitro analysis to perform quality control for biophar­ma­ceu­ti­cals and other phar­ma­ceu­ti­cals and to test raw mate­rials, phar­ma­ceu­tical prod­ucts and bacte­rial cell banks for micro­bial impu­ri­ties and residues.

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
pharma&med pharma bioanalytik Labor

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.

All phar­ma­ceu­ti­cals avail­able on the market must also undergo contin­uous stability testing to prove their durability.

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.

In partic­ular, terpene screening allows us to deter­mine whether pyrrolizidine alka­loids are present in medi­c­inal cannabis.

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.

Our stan­dard­ised and trans­parent batch certi­fi­ca­tion processes provide assur­ance for our clients that they have met offi­cial require­ments, while clearly setting out respon­si­bil­i­ties and defining interfaces.

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.

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