Bioanalytical & biopharmaceutical analysis

Cambrex has extensive experience in Drug Metabolism and Pharmacokinetic (DMPK), Bioanalytical and Biopharmaceutical Analyses. The Biopharmaceutical Analyses scope supports GMP method development, validation, and routine analysis including but not limited to host cell proteins, host cell DNAs, endotoxins, enzyme kinetics, and even bacteriophage titering assays. The Drug Metabolism and Pharmacokinetic (DMPK) scope supports pre-clinical discovery and development utilizing state-of-the-art instruments including High Resolution and LC-MS/MS. In addition, Cambrex has experience with metabolite identification (ID) from such studies.

Cambrex Biopharmaceutical Analyses

  • Advanced Biopharmaceutical Method Development
  • Method Validation (GMP) and Method Qualification (non-GMP) Protocols and Execution
  • Stability Protocols and Execution
  • Routine Sample Analyses (GMP and R&D)
  • GMP Bacteriophage Titering, and SDS page (ChemiDoc)
  • Host Cell Protein (Microplate based with Western Blot Coverage for mid- to late- phase programs)
  • Host Cell DNA (qPCR)
  • Endotoxins (USP<85>), Enzyme Kinetics, Total RNA, Total Protein, and ELISAs (Microplate reader)

Cambrex DMPK – Bioanalytical Services

ADME

  • Hepatocyte Stability
  • Microsomal Stability
  • S9 Stability
  • Plasma Stability
  • Simulated Fluid Stability
  • Tissue Stability
  • Reactive Metabolite Assessment (Glutathione Trapping)
  • Metabolite Identification (in vitro and in vivo)
  • CYP Inhibition
  • PAMPA
  • Franz Diffusion Cell Permeability
  • Tissue Binding
  • Microsomal Protein Binding
  • Plasma Protein Binding
  • Whole Blood Binding
  • Blood to Plasma Ratio (in vitro and in vivo)
  • Blood/Plasma to Tissue Ratio

Bioanalysis

  • Advanced Bioanalytical Method Development
  • Pharmacokinetics (PK) Services
  • In vivo Protocol Drafting
  • In vitroin vivo Correlation
  • Cassette Dosing and Analysis (N-in-one)
  • Pre-Formulation to Enable in vivo Work
  • Non-clinical PK Management and Data Interpretation

Integrated Services

  • Hit-to-lead and Lead Optimization

Get in touch with Cambrex

To learn more about our bioanalytical and biopharmaceutical services, get in touch with the Cambrex team via our contact page.

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