Method Development and Validation

PPD's cGMP analytical labs perform methods development and validation for a broad spectrum of pharmaceutical compounds and dosage forms during various drug development stages, including methods for:

• A wide range of chromatography techniques (HPLC, UPLC, GC, SEC and IC) and detection technologies (UV, FL, MS, ELSD, RI, FID, TCD, MALS, CAD, etc.) to meet the requirements for different types of compounds
• Stability-indicating assay and/or related substances methods for drug substance and drug products (tablets, capsules, suspensions, creams, injectables, nasal sprays, pMDIs, medicated feeds, drug-eluting stents, etc.)
• Dissolution (IR, ER, MR)
• Organic volatile impurities
• Preservatives and antioxidants
• Enantiomeric separation
• Clinical comparator assay and dissolution
• Cleaning validation on various surfaces by HPLC, UPLC, TOC and GC
• Dose verification for GLP studies

The analytical development group also provides method development experimental design, interim progress reports for method development, method validation protocol development and preparation, gap analyses, and remedial method validation and customized method validation reports.

Analytical Testing Services

PPD's analytical testing services have the capability to evaluate the following dosage forms:

• Tablets and capsules (IR, MR, ER)
• Liquids
• Suspensions
• Lyophilized powders
• Injectables
• Stents
• Implantable devices
• Others

Analytical Laboratory Services Offered Include:

• Method optimization, qualification, validation and transfer
• Release and in-process testing, including expedited services
• Stability protocol development and program management
• Stability storage and testing
• Stability data trending
• Physical chemistry testing
• Compendial testing (USP, EP, BP, JP and FCC)
• Microbiological testing
• Analytical support for cleaning and process validation
• Pre-formulation testing
• Analytical support for formulation development
• Compatibility studies
• Reference standard characterization
• • Materials characterization
  • Thermal analyses
  • Particle-size characterization
  • Microscopy
  • Spectroscopy (FTIR, LC-MS, GC-MS, UV, FL, etc.)

PPD has a wide range of analytical laboratory instrumentation (Adobe Acrobat file, 217 Kb)

Specialized Analytical Technologies

PPD's cGMP analytical labs offer comprehensive, specialized technologies to effectively support your drug development research and testing needs:

• Synoptics Automated Colony Counting and Measuring System
• Dupont Qualicon Ribo Printer® System
• CPS Barrier Systems Isolator
• Dionex Automated Solvent Extractor (ASE)
• Thermo Elemental ICP-MS
• Agilent GC/MS equipped with both CI and EI ionization modes
• • Coupled with Frontier Lab's Pyrolyzer
• LC/MS/MS
• • Waters Q-Tof Premier coupled with HPLC
  • Waters® ACQUITY® TQ Detector coupled with UPLC
  • Applied Biosystems/MDS SCIEX 4000 QTRAP® System coupled with HPLC
  • Applied Biosystems/MDS SCIEX API 3000™ System
  • Applied Biosystems/MDS SCIEX API 2000™ System
  • Agilent Single Quad
• Waters preparative HPLC system
• HPLC systems equipped with the following detectors:
• • UV/PDA
  • FL
  • RI
  • ELSD
  • ESA Corona Charged Aerosol Detection (the Corona® CAD™)
  • Radiochromatography Detector (beta-Ram 4B)
• Varian BIO-DIS III Extended Release Testing Station, USP Apparatus III
• SOTAX flow-through cell system, USP Apparatus IV
• Laser light scattering and macromolecule characterization
• • Wyatt miniDawn with Optilab DSP
  • Wyatt Dawn EOS with Optilab rEX and WyattQELSTM (Quasi-Elastic—Light-Scattering) Detector
• Pre-formulation and material and product characterization
• • NiComp 380
  • Malvern Zetasizer Nano ZS90
  • Sympatec HELOS
  • Optical microscopes
  • Liquid particle counting systems
  • Elemental analyzer
  • VTI Dynamic Water Sorption Analyzer
  • TA Instruments Differential Scanning Calorimeter (DSC)
  • TA Instruments Thermogravimetric Analysis (TGA)
  • ICH Option I Photostability Chambers (forced degradation study)
  • • Atlas Suntest CPS+
    • Atlas Suntest XLS+
  • ICH Option II Photostability Chambers (drug confirmatory testing)
  • • PGC Light Chamber
    • Sanyo Light Chamber

Structural Chemistry Services

PPD supports extensive structural chemistry services for small and large molecules that include:

• Impurity and degradation product identification and structural elucidation
• Characterization of API, product, reference standard and other pharmaceutical ingredients
• Trace element analyses and quantitation
• Accurate mass determination for small molecules
• Molecular weight determination for large biomolecules

Synthesis, Purification and Characterization

PPD also offers small molecules synthesis, purification and characterization services that include:

• Synthesis of analytical standards
• • Drug and drug candidate standards
  • Manufacturing process impurities
  • Degradation impurities
  • Metabolite standards
  • Stable-labeled (2H, 13C, 15N) internal standards
• Support of drug development research
• • Milligram to multigram synthesis of target compounds
  • Synthetic route development and route optimization
  • Process optimization
• Synthesis of fluorescently labeled probes for various receptor sites (e.g., nuclear hormone receptors and ion channels)
• Purification and complete analytical characterization