Bioanalytical & Biopharmaceutical Analysis Services
From Analytical Services
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.
Servcies Overview
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 vitro – in 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
Customer reviews
No reviews were found for Bioanalytical & Biopharmaceutical Analysis Services. Be the first to review!