GMP-certified contract laboratory service provider for pharmaceutical analytics, stability testing and quality control since 1995.
A&M STABTEST Labor für Analytik und Stabilitätsprüfung GmbH
Bergheim · MainzNew on Amplifa
About us
A&M STABTEST GmbH is a contract research laboratory founded in 1995 as a spin-off from A&M Labor für Analytik und Metabolismusforschung GmbH, headquartered in Bergheim near Cologne. The company, with more than 250 employees, specializes in pharmaceutical analytics of small molecules and biomolecules. Its service portfolio includes stability testing with approximately 800 m³ of storage capacity, quality control including in-process controls and release analytics (over 3,500 release tests per year), analytical development and method validation, dissolution testing, bioassays, mass spectrometry (GC-MS, LC-MS, ToF, Orbitrap), extractable & leachable testing, inhalation analytics (DPI, pMDI, nasal sprays, nebulizers), bioanalysis and ATMP analytics. The laboratories are bound to the cGMP guidelines of the EMA, FDA and ICH and are regularly inspected by regional authorities as well as the US FDA. The sister company A&M Labor für Analytik und Metabolismusforschung GmbH has been GLP-certified since 1991. Customers come from the pharmaceutical industry, biotechnology, cell and gene therapies (ATMP) and veterinary pharmaceuticals.
- Site
- Bergheim
- Processes
- Pharmaceutical analytics, Quality Control Analytics, Analytical Development, Bioassay, Mass spectrometry, Extractable & Leachable Testing, Inhalation Analytics, Stability storage and logistics
- Materials
- Mass Spectrometry (GC-MS, LC-MS, ToF, Orbitrap), Inhalation Analytics, Dissolution Testing, Bioassay and Bioanalysis, Extractable & Leachable Testing, Stability Testing
- Certificates
- GMP Certificate Human Medicines (cGMP EMA/ICH), GMP Certificate Veterinary Medicines, GMP Certificate Mainz (Art 111(5) and 15, Directive 2001/83/EC), GMP Certificate Mainz (Art 94(1), Regulation (EU) 2019/6), FDA Certificate Bergheim, FDA Acceptance Letter Mainz, Manufacturing Authorization Veterinary Bergheim, Manufacturing Authorization Veterinary Mainz, GMP Certificate Mainz (Directive 2001/83/EC), GMP Certificate Mainz (Regulation (EU) 2019/6), FDA Certificate/Inspection, Manufacturing Authorization Veterinary
- Founded
- 1995
- Employees
- 250+
- Industries
- Pharmaceutical industry, Biotechnology, Cell and gene therapies (ATMP), Veterinary pharmaceuticals
- 01
Sample receipt and stability storage
- 02
Analytical development and method validation
- 03
Pharmaceutical analytics (HPLC, GC, MS)
- 04
Release and quality control analytics
- 05
Report preparation and regulatory documentation
Processes and Methods
Mass Spectrometry (GC-MS, LC-MS, ToF, Orbitrap)
Identification of unknown compounds, quantification of impurities and characterization of biopharmaceuticals (top-down and bottom-up).
Inhalation Analytics
Determination of the aerodynamic particle size distribution (APSD) and delivered dose for DPI, pMDI, nasal sprays and nebulizers.
Dissolution Testing
Release testing for solid and semi-solid dosage forms as well as transdermal therapeutic systems (TTS).
Bioassay and Bioanalysis
GLP- and GCP-compliant analytics of PK/TK studies, biomarkers and ADME research.
Extractable & Leachable Testing
Investigation of extractable and leachable substances for pharmaceutical products.
Stability Testing
Stability storage and testing of active ingredients and dosage forms including tablets, capsules, parenteral and topical forms, inhalables and transdermal systems.
Locations
Bergheim
DEHeadquarters and Laboratory
- Materials
- small molecules, biomolecules
- ToF mass spectrometer (high-resolution)
- Orbitrap mass spectrometer
- GC-MS
- LC-MS
- Andersen cascade impactor
- Next-Generation Impactor
- Laser diffraction device
- Artificial lung (simulation device for nebulizers)
- Dissolution test systems
- humidity- and temperature-controlled special laboratory
Mainz
DELaboratory/Stability
Service Areas
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Pharmaceutical analyticsTesting | – | – | – | – | small molecules, biomolecules |
| Quality Control AnalyticsTesting | – | – | – | – | – |
| Analytical DevelopmentTesting | – | – | – | – | – |
| BioassayTesting | – | – | – | – | – |
| Mass spectrometryTesting | – | – | – | – | small molecules, proteins, nucleic acid active ingredients |
| Extractable & Leachable TestingTesting | – | – | – | – | – |
| Inhalation AnalyticsTesting | – | – | – | – | – |
| Stability storage and logisticsTesting | – | – | – | – | – |
| BioanalysisTesting | – | – | – | – | – |
| ATMP AnalyticsTesting | – | – | – | – | – |
| Stability testingTesting | – | – | – | – | active ingredients from tablets, suppositories, capsules, parenteral dosage forms, topical dosage forms, transdermal systems, inhalables, active-ingredient-coated implants |
| Analytics of inhalable products (APSD, delivered dose, DPI, MDI, LNP)Testing | – | – | – | – | LNP-formulated mRNA, DNA-based active ingredients, nanoparticle formulations |
| Dissolution Testing (release testing)Testing | – | – | – | – | solid and semi-solid dosage forms, transdermal therapeutic systems (TTS) |
| Nasal spray testing (shot weight uniformity, spray pattern, droplet size distribution)Testing | – | – | – | – | – |
| Nebulizer testing (nebulizer solution, collection using an artificial lung)Testing | – | – | – | – | – |
| Characterization of biopharmaceuticals (top-down & bottom-up MS)Testing | – | – | – | – | proteins, nucleic acid active ingredients, biomolecules |
| Identification of unknowns (GC-MS, LC-MS, Orbitrap)Testing | – | – | – | – | – |
| Quantification of impuritiesTesting | – | – | – | – | – |
| Method validationTesting | – | – | – | – | – |
10 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| ToF mass spectrometer (high-resolution) | – | – | – | – | Bergheim |
| Orbitrap mass spectrometer | – | – | – | – | Bergheim |
| GC-MS | – | – | – | – | Bergheim |
| LC-MS | – | – | – | – | Bergheim |
| Andersen cascade impactor | – | – | – | – | Bergheim |
| Next-Generation Impactor | – | – | – | – | Bergheim |
| Laser diffraction device (droplet size distribution) | – | – | – | – | Bergheim |
| Artificial lung (simulation device for nebulizers) | – | – | – | – | Bergheim |
| Dissolution test systems (paddle, basket, sinker systems, paddle over disk) | – | – | – | – | Bergheim |
| humidity- and temperature-controlled special laboratory | – | – | – | – | Bergheim |
Additional services
Quality
The laboratories are bound to the cGMP guidelines of the EMA, FDA and ICH. Regional authorities and the US FDA verify compliance in regular inspections; customer audits additionally confirm the quality systems.
| Evidence | Bergheim | Mainz |
|---|---|---|
| GMP Certificate Human Medicines (cGMP EMA/ICH) | ||
| GMP Certificate Veterinary Medicines | ||
| GMP Certificate Mainz (Directive 2001/83/EC) | ||
| GMP Certificate Mainz (Regulation (EU) 2019/6) | ||
| FDA Certificate/Inspection | ||
| Manufacturing Authorization Veterinary |
History
- 1990
Founding of the sister company A&M Labor für Analytik und Metabolismusforschung GmbH
- 1991
Sister company certified under GLP as Germany's first bioanalytical contract research laboratory
- 1995
Founding of A&M STABTEST GmbH as a spin-off by Dr. Donald N. Dill, Dr. Hans J. Diehl, Dr. Hartmut Fischer and Dr. Axel Römer
- 2001
First FDA inspections; repeated FDA inspections without deficiencies since then