G(C)LP & 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.
Your direct contact
Dr. Daniel Da Costa
BD Director Preclinical Services Europe
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).
