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G(C)LP & non-GLP Bioanalytics

GBA Group - G(C)LP and non-GLP bioanalytics

Highest quality analyses

The GBA Group's bioanalytic team performs highest quality analyses with latest edge technology. We support our in house in vitro and in vivo studies as well as external preclinical and clinical studies with diligence and dedication.

In addition, we provide services for compound discovery, database queries of relevant DB, impurity identification, extractable and leachable studies.

Our dedicated team quantifies compounds and their metabolites in wide range of sample types for several compound classes.

Contact at Pharmacelsus

Your direct contact

MUDr. Maria Li
Director Business Development

Mobile: +49 173 889 4288


MS Equipment

  • UHPLC-MS/HRMS (Q-Exactive Plus)
  • 2 x UHPLC-MS/HRMS (Q-Exactive)
  • UHPLC-Q-TOF (X500 B)
  • 2 x HPLC-MS/MS Triple Quadrupole MS

Compound Classes

  • Small molecules
  • Peptides
  • Plant-extracts
  • Oligo- and polymers

Sample Types

  • Clinical and non-clinical samples
  • Blood, plasma (any species)
  • Tissues (including fat and skin)
  • Urine, faeces, bile
  • Cell culture medium
  • Liquid preclinical dosage forms
  • Others
    • (please contact us)

Metabolite Identification

  • Software: Compound Discoverer
  • In vitro, in vivo and clinical samples
  • Proposed metabolic pathway
  • Proposed chemical metabolite structure
  • MS/HRMS-Fragment analysis
  • Accurate mass

Quantification of Biomarkers

  • E.g. Bile acids in clinical and non-clinical samples
  • Please contact us for your specific biomarkers

G (C)LP Bioanalytics

Method validation and study sample analysis according the bioanalytical guidelines of EMA (2012) and FDA (2018)

Method Development Sample Preparation

  • Protein precipitation, liquid extraction, solid phase extraction (SPE)
  • Optimisation
  • Pre-validation:
    • Test for selectivity
    • Check for robustness
    • Determine recovery
    • Check for matrix effects

Method Development LC-MS

  • Choose chromatographic method: MS-Technology (MS/HRMS or high-resolution HRMS)
  • Optimization
  • Definition of calibration range
  • Pre-validation:
    • Robustness of chromatography
    • Test for selectivity by MS check for matrix effects

GLP Validation Sample Preparation

  • Test sample stability (storage in frozen state, handling in liquid state)
  • Test analytical samples stability (storage in autosampler and freezer)
  • Test matrix effects (robustness of methods and selectivity with at least six individual matrices)
  • Determination of recovery

GLP Validation LC-MS

  • Performance of at least three validation batches:
    • Calibration curve
    • Intra-/inter-run accuracy
    • Intra- /inter-run precision
    • Selectivity tests of MS
    • Validate peak form and carry over
    • Validate reinjection procedures

Preclinical GLP Bioanalytics*

  • Pharmacelsus acts as GLP test facility and as test site for multisite studies. QA inspection of all study phases: study plan, experimental phase, retain samples, data processing, reporting and archiving. Application of fully qualified and calibration equipment.

*According to the actual EMA/FDA/ICH Guidelines

Clinical GC(L)P Bioanalytics*

  • Close cooperation with the clinical CRO of your choice
  • Maintenance of “chain of custody”
  • QA inspection of all study phases
  • Application of fully qualified and calibrated equipment.

*According to the actual EMA/FDA/ICH Guidelines

Instrumentation / Qualification

  • GLP certified laboratory for the categories 8 and 9
  • Use of validated computerized systems
  • Mass spectrometer and HPLC:
    • Qualified equipment
    • Regular maintenance
    • Regular calibration
    • Regular/(Re)-qualification

Data / Archiving

  • PK data evaluation
  • Data are archived according to GLP guidelines
  • GLP retain samples are archived according to “Deutsches Chemikaliengesetz”)

    Full documentation and work according standard operating procedure (SOP).

Our Flyers

Non-GLP Services

Non-GLP Services

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Bioanalytical lab for clinical services (GCLP)

Bioanalytical lab for clinical services (GCLP)

The experienced and highly committed GBA Group team offers a variety of different services the following in Areas:

GBA Group - In vitro ADME

In vitro ADME

GBA Group - In vivo DMPK

In vivo DMPK

GBA Group - In vitro & in vivo Toxicology

In vitro & in vivo Toxicology

GBA Group - G(C)LP & non-GLP Bioanalytics

G(C)LP & non-GLP Bioanalytics

GBA Group - Biomarker Services

Biomarker Services

GBA Group - In vitro & in vivo Pharmacology

In vitro & in vivo Pharmacology

GBA Group - Preclinical Services

Preclinical Services

GBA Group Pharma

GBA Group Pharma

Business Development

Contact us!

To learn more about us and what we can do for you please contact our Director Business Development.

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