© science photo / Fotolia

Pharmacelsus

G(C)LP & non-GLP Bioanalytical Services

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, Extractible 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 at 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 purity
    • Check for robustness
    • Determine recovery
    • Check for matrix effects

Method Development LC-MS

  • Choose chromatographic method:
    MS-Technology (MS/HRMS or high-resolution HRMS)
  • Optimisation
  • 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)
  • Determine 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 calibrated 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 maintainance
    • Regular calibration
    • Regular/(Re)-qualification

Data / Archiving

  • PK data evaluations using validated software packages (e.g. KineticaTM, WinNonlin)
  • 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
Business Development & Sales
li@pharmacelsus.de

Dr. Peter Ehmer
Team Manager GLP
ehmer@pharmacelsus.de

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