G(C)LP & non-GLP Bioanalytics
State-of-the-art HPLC and GC mass spectrometry analyses
The GBA Group's bioanalytics team delivers top-tier quality analyses using the latest edge technology. We support both our in house in vitro and in vivo studies, as well as external preclinical and clinical studies with precision, diligence and commitment. In addition, we offer comprehensive services for compound discovery, database queries of relevant DB, impurity identification, extractable and leachable studies. Our dedicated and experienced team quantifies compounds and their metabolites across a wide range of sample matrices GC1.1for several compound classes.
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
- 2 x UHPLC-MS/HRMS (Q-Exactive Plus)
- 2 x UHPLC-MS/HRMS (Q-Exactive)
- GC-MS/MS Triple Quadrupole Mass Spectrometer (TSQ 9610)
- Instruments embedded into Chromeleon (chromatography data system)[
Compound Classes
- Small molecules
- Peptides
- Oligonucleotides
- 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 phase I/II 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
- Specific biomarkers on demand
G (C)LP Bioanalytics
Method validation and study sample analysis according to the bioanalytical guidelines of the ICH and EU
Method Development Sample Preparation
- Protein precipitation, liquid extraction, solid phase extraction (SPE), headspace, SPME
- Optimization
- 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*
- We act as a GLP test facility for multisite studies. QA inspection of all study phases: study plan, experimental phase, retained samples, data processing, reporting and archiving.
- Fully qualified and calibration equipment
*According to the current ICH/EMA/FDA/EU regulations (e.g. ICH M10, ICH Q2, and the guideline SANTE/2020/12380 (Rev.2))
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
- Fully qualified and calibrated equipment
*According to the current ICH and EU regulations (e.g. ICH E6 (R3) and the EU regulation 536/2014 (CTR))
Instrumentation / Qualification
- GLP certified laboratory for the categories 8 and 9
- Use of validated computerized systems
- Mass spectrometer and HPLC or GC:
- Qualified equipment
- Regular maintenance
- Regular calibration
- Regular/(Re)-qualification
Data / Archiving
- PK data evaluation
- GLP archiving
- GLP retained samples according to the German Chemicals Act (ChemG)
Full documentation and work according to standard operating procedures (SOPs).
Quality Assurance & Regulatory Relevance
GBA Group conducts bioanalytical studies under quality-controlled processes and systems (GLP, SANTE, ISO...) with rigorous data integrity. Our approach ensures that your bioanalytical data are:
• Scientifically robust
• Traceable and auditable
• Suitable for integrated safety assessments and/or regulatory submissions
Consultative Project Support
We work collaboratively with your team to:
• Tailor bioanalytical study design
• Integrate bioanalysis with ADME, DMPK and toxicology
• Interpret results in the context of overall drug research and development strategy
This consultative framework helps you optimize study value and meet project milestones with confidence.
Download the Bioanalytical Services Flyer
Access a detailed overview of our bioanalytical, endpoints, and deliverables to assist planning and sponsor discussions.
