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Analytical Services for Drug Products

Patheon is one of the world’s leading contract develop and manufacturing organizations inpart due to the repeatable high quality made possible by our exceptional analytical services team. They will support your project at every phase with a comprehensive array of services, including:

  • Process development andvalidation
  • Analytical R&D support
  • Structure elucidation
  • Solid form definition & analysis
  • Impurity tracking
  • Physicochemical properties
  • Characterization of referencestandards
  • Analytical development andvalidation
  • In-process production support
  • Stability testing, at varioustemperatures and durations
  • Genotox studies
  • PAR studies

Our highly efficient in-house labs at every manufacturing and development site will provide comprehensive services from the quick characterization of your molecule, to the development and implementation of cGMP laboratory methodologies and the generation of data for your regulatory submissions. With a very small amount of API, Patheon can provide you with a wealth of information and expertise to guide your next steps – advice rooted in experience with thousands of different molecules.

When working with Patheon, you’ll feel confident in the high quality of your product, processes and business decisions because of the high quality of the analytical data they’ll be built upon.

No matter what the demands of your project, Patheon offers the full-breadth of analytical services and capabilities to ensure that you always have access to the tools and know-how you need:

Early Development Analytical Services

  • Chemical Purity Analysis
    • HPLC and UPLC analysis
  • Physicochemical Properties
    • Drug Substance Analysis
      • FTIR and appearance
      • Polarized and hot stage microscopy
      • TGA/DSC, pXRD and DMS
    • Preformulation Assessment
      • Aqueous and solvent solubility
      • KF, pKa and logD
      • Solution and solid state stability
    • Analytical Method Development (non-GMP)
      • Stability indicating assays
      • Assay and degradants
      • Related substances
  • Solid Form Definition and Analysis
    • pXRD: Crystallinity
    • DSC: Thermal Transitions and Melt
    • Dynamic Moisture Sorbtion: Hygroscopicity
    • Polarized and Hot Stage Microscopy: Particle size range, shape and morphology, as well as melting characteristics
  • Molecular Structure Analysis
    • HPLC and UPLC
    • Detailed Analysis of Drug Substance Lots
      • Test for new impurities or degradants
    • Generation of Proposed Structures
      • LC-MS/MS and predictive software: Lhasa Limited Zeneth and DEREK (Deductive Estimation of Risk from Existing Knowledge)
  • Excipient Compatibility Testing
    • UPLC, HPLCs with UV, RI, PDA, Electrochemical, Conductivity, MS, and Fluorescence Detectors and GCs with FID and TCD
    • ICP/AA
    • TGA and DSC
    • IR, UV, and NIR Spectroscopy
  • Preformulation Assessment
    • Amorphous vs. Crystalline Solid State Testing
    • Aqueous and Solvent Solubility
    • Solution and Solid State Stability
    • Vehicle Screening for ADME and Tox
  • Analytical Method Development and Validation (GMP)
    • IND Phase-Appropriate
    • Cleaning Residual Assays
    • Stability Indicating Assays
      • UPLC and HPLC
      • Forced degradation studies
    • Related Substances
      • Chiral purity
      • Residual solvents analysis
    • Dissolution Testing
    • Preservative Assays
    • Physical Methods
      • Laser diffraction
      • Karl Fisher water determination
    • Nasal Spray Characterization
      • Droplet size, spray pattern, spray content uniformity
  • Release and Stability Testing
    • In-Process and Release Testing
      • HPLC, TLC, UV and FTIR
      • Physical testing: Appearance, color, weight variation, viscometry, deliverable volume
      • Particle size by laser diffraction, wet and dry sampling
      • XRPD, TGA, DSC
      • Wet chemistry tests: USP, EP, JP
      • Assay and related substances: UPLC, HPLC and GC
      • Anti-oxidant/preservative assay
      • Chiral analysis
      • Content and blend uniformity
      • Genotoxic impurity analysis: LC/MS
      • Residual solvents: OVI
      • KF: Volumetric, coulometric
      • Dissolution: Immediate release and enteric coated – USP Apparatus I & II (1- and 2-stage dissolution profiles), III, IV and VII
      • Metal content: ICP, AA
      • Microbiological testing: MLT, MET, sterility and endotoxin
    • Stability Studies
      • Computerized stability management system
      • ICH stability storage conditions
      • Climatic zones I-IV or custom conditions, including low RH
      • Photostability: Options 1 and 2
      • Freeze/thaw cycling studies
  • Clinical Trial Material Manufacturing Support
    • Small and large molecules, as well as biologics
    • Dose escalation studies
    • Formulation scalability stabilization studies
    • Release testing
  • IND/IMPD Dossier Support
    • Chemistry, Manufacturing and Controls (CMC) documentation

Late Development Analytical Services

  • Method Development and Validation: ICH Q2 and USP
    • Cleaning residual assays
    • Stability indicating assays including forced degradation: UPLC, HPLC and GC
    • Related substances, chiral purity, residual solvents determinations
    • Dissolution testing
    • Preservative assays
    • Physical methods: laser diffraction, Karl Fisher
    • Nasal spray characterization: Droplet size, spray pattern, spray content uniformity
  • Release Tests
    • ID: HPLC, TLC, UV, FTIR
    • Physical testing: Appearance, color, weight variation, viscometry, deliverable volume
    • Particle size by laser diffraction: wet and dry sampling
    • Wet chemistry tests: USP, EP and JP
    • Assay (UPLC, HPLC, GC) and related substances
    • Anti-oxidant/preservative assay
    • Chiral analysis
    • Content and blend uniformity
    • Residual solvents: OVI
    • KF: volumetric, coulometric
    • Dissolution: Immediate release, enteric coated, delayed release, extended release and pulsatile: USP apparatus I & II (1- and 2-stage dissolution profiles), III, IV and VII
    • Abuse deterrent testing, including: alcohol dose-dumping
    • Metal content: ICP and AA
    • Microbial testing: MLT, MET and sterility
    • Preservative efficacy testing
  • Stability Studies
    • Computerized stability management system
    • ICH stability storage conditions
    • Climatic zones I-IV, custom conditions, low RH
    • Photostability: Options 1 and 2
    • Freeze/thaw cycling studies
  • IND/IMPD Dossier Support
    • Chemistry, Manufacturing and Controls (CMC) documentation

Biologics Analytical Services

  • Electrophoresis and Blotting
    • Capillary electrophoresis: CE-SDS and cIEF
    • Reducing & non-reducing SDS-PAGE
    • Isoelectric focusing
    • Western blotting
  • Functional Activity Assays
    • Micro-titre plate based assays: ELISA
  • Protein Concentration Determination
    • UVA280
    • Colourimetric methods: BCA assay
  • HPLC and UPLC Methods
    • Size exclusion
    • Ion exchange
    • Reversed phase
    • LCMS
  • Pharmacopoeial Testing for Parenterals
    • Sub-visible particle counting
    • Moisture determination
    • Color
    • Turbidity/opalescence
    • Osmolality
  • Structural Characterization
    • Mass spectrometry

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