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G(C)LP & Non-GLP Bioanalytics

Highest quality analyses

The Pharmacelsus 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.

Dr. Peter Ehmer, Project Leader Method Validation (GLP) says: “Pharmacelsus is a GLP certified test facility and supports the regulated bioanalysis of preclinical toxicological studies. Clinical trial samples are analyzed under GCLP conditions. Analytical method validations and sample analysis for the chemical industy in the field of ecotoxicology and agrocultural chemistry complete our regulated portfolio.”

  Our dedicated team quantifies compounds and their metabolites in wide range of sample types for several compound classes. Please contact Dr. Fredy Kern kern@pharmacelsus.de for more information about metabolite identification techniques.

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).

Please contact us for your specific bioanalytic study.

MUDr. Maria Li
 Director Business Development
li@pharmacelsus.de

Dr. Peter Ehmer 
GLP 
ehmer@pharmacelsus.de

Dr. Klaus Biemel
 DMPK & Bioanalytics
 biemel@pharmacelsus.de