Testing Lab Services

MDx BioLabs provides comprehensive analytical and research support for pharmaceutical development, clinical research, and industrial applications. Our services cover the full spectrum of testing needs for small molecules, biologics, peptides, and raw materials. We specialize in the following:

• Study Sample Analysis: Analytical characterization of small and large biomolecules across preclinical and clinical phases.
   
• Protein and Peptide Characterization:
   
  • Molecular weight determination
     
  • Purity and net-peptide analysis
     
  • Aggregation profiling
     
  • Sequence confirmation and PTM analysis via MALDI-TOF MS
     
• Stability Studies: ICH-compliant stability testing, including forced degradation and shelf-life estimation.
   
• Bioinformatics & Mass Spectrometry:
   
  • Biomarker discovery and validation
     
  • Peptide mapping
     
  • Proteomic profiling
     
• qPCR-Based Molecular Analysis:
   
  • Gene expression quantification
     
  • Copy number variation
     
  • Pathogen detection (e.g., COVID-19)
     
  • Microbial ID and quantification
     
• Microbiological Testing:
   
  • Bioburden, TAMC, TYMC
     
  • Endotoxin testing (gel clot, kinetic turbidimetric methods)
     
  • Absence of specific microorganisms
     
  • Microbiological assay of antibiotics
     

HPLC Detection Methods:

• HPLC-UV, HPLC-DAD, HPLC-RID, HPLC-FID
   
• Applications:
   
  • Impurity profiling
     
  • Quantitative assay of active ingredients
     
  • Residual solvent analysis
     
  • Degradation product identification
     
  • Size exclusion chromatography for aggregation
     

Spectroscopy & Chromatography:

• FTIR (Fourier-Transform Infrared Spectroscopy):
   
  • Functional group identification
     
  • Raw material ID
     
  • Polymer and excipient analysis
     
• UV-VIS Spectrophotometry
   
• Thin Layer Chromatography (TLC)
   
• Gas Chromatography (GC)
   

Wet Chemistry Techniques:

• Assays and Titrations:
   
  • Acid, ester, hydroxyl, iodine, peroxide, and saponification values
     
  • Amperometric, complexometric, and potentiometric titrations
     
• Physical & Chemical Characterization:
   
  • Boiling & freezing points
     
  • pH (standard and potentiometric)
     
  • Osmolality
     
  • Optical rotation
     
  • Refractive index
     
  • Viscosity (capillary and rotational)
     
  • Water content via Karl Fischer and loss on drying
     
  • Melting point, drop point, distillation range
     
  • Elemental analysis (AA, AE, graphite furnace, hydride system)
     

• Identification and Purity Testing
   
• Clarity, Opalescence, and Color
   
• FTIR for material confirmation and excipient profiling
   
• Residuals: Sulphated ash, total ash, ethylene oxide, dioxane
   
• Particulate Matter Analysis
   

Applicable across industries:

• Pharmaceutical
   
• Medical Device
   
• Cosmetic

*ISO/IEC 17025:2017 ACCREDITIED