A strong suite of analytical services is essential to effective delivery of high-quality clinical supplies. Every step of process development, formulation development, and the manufacturing of clinical trial materials requires a series of good decisions based on good analytical data to keep your program moving forward on schedule.

At each of our CDMO sites our GMP/GLP analytical laboratories are ready to provide a broad range method development services, phase-appropriate method validation, and routine quality-assessment testing in support of formulation development and clinical supplies manufacturing. In addition to the on-site capabilities and capacity, the full range of expertise and analytical capabilities from our network of laboratories is readily available to support specialty needs that may arise. Our team of scientists and professionals work together throughout our network help your programs stay on schedule and moving through the clinic.

As your product advances through preclinical and clinical phases and moves toward commercialization, technology transfer to our FDA-registered, GMP laboratory testing facilities enables seamless and confident progress. Our GMP central laboratory services ensure studies are appropriately transferred, validated and executed in a manner compliant with regulations and industry standards.

 

Preformulation/Solid State Characterization

  • Drug-Excipient Compatibility Studies
  • Differential Scanning Calorimetry (DSC)
  • Powder X-ray Diffraction (XRD)
  • Polarized Light Microscopy (PLM)
  • Scanning Electron Microscopy (SEM)
  • Particle Size Analysis (LLS)
  • Forced-Degradation Studies
  • Solubility Determination (aqueous/solvents)
  • Intrinsic Dissolution (paddle over disk)
  • Texture Analysis
  • Bulk Powder Characterization

Development & Analysis

  • Assay
  • Potency
  • Related Substances
  • Chiral Purity
  • Residual Solvents
  • Dissolution
  • USP Apparatus I
  • USP Apparatus II
  • Intrinsic Dissolution (paddle over disk)
  • Identification
  • UV/Vis spectrophotometry
  • FTIR spectroscopy
  • Cleaning Verification
  • Compound specific methods (HPLC)
  • Total Organic Carbon (TOC)
  • Other
  • Karl Fischer Titration
  • Viscosity Measurement
  • pH Measurement
  • Color Spectrophotometry