Analytical Instruments and Storage

• General laboratory technologies
• Specialized inhalation technologies
• Specialized biopharmaceutical technologies

General Laboratory Technologies

• Most major brands of HPLC are offered:
  • Detectors: UV, PDA, RI, Fluorescence and ELSD
• GC - Agilent 6890 and Perkin Elmer AutoExcel:
  • Specialized injection mode: headspace analyzer and cool-on column
  • Detection: FID, TCD, ECD, FPD
• Agilent GC/MS:
  • CI & EI ionization modes
• SCIEX 300, SCIEX 2000 and SCIEX 365:
  • APCI & ESI ionization modes
• Ion chromatography
• ICP-MS and ICP-OES
• FTIR spectrophotometer
• UV-visible spectrophotometers
• Hunter colorimeter
• USP dissolution - apparatus I, II, III & IV
• Coagulation analyzer
• Zymark multidose automated dissolution system
• Karl Fischer coulometric and titrimetric titrators
• Multiple potentiometric titrators
• Densitometer
• Total organic carbon analyzer
• Hardness testers
• Sieving:
  • RoTap
  • Air-Jet
• Osmometer
• Viscometers
• Turbidiometer
• USP particulate matter:
  • HIAC particulate matter analyzer
  • Microscope
• DSC
• TGA
• Atomic absorption:
  • Flame and graphite furnace
• USP and JP disintegration

• Environmentally Controlled Laboratories for Aerosol Performance Testing with high capacity house vacuum
• Next generation impactors (NGI)
• Fast-Screening Impactor (FSI)
• Andersen cascade impactors (ACI)
• Marple-Miller Impactor M150 (MMI)
• Multi-stage liquid impinger (MSLI)
• Malvern Spraytec droplet size analyzer
• HIAC Royco particulate matter analyzer
• Patented US PTO #7,934,434) DPI Particle Matter Collection Tubes
• Sierra Instruments top-trak and TSI digital flow meters
• Copley Scientific
• • Copley Inhaler Testing Data Analysis Software (CITDAS, v 3.11)
  • Model TPK critical flow controller
  • “Gentle Rocker” Dissolution Tool for NGI
• Innova Systems
• • Nasal dose weight collection station (NSP-DWCS)
  • MDI FD-10 automated bursting station
  • Nasal spray pump actuation station (eNSP, Mighty Runt)
• Proveris Imaging Systems for Plume Geometry and Spray Pattern
• Optronics imaging system for optical microscopy

Specialized Formulation Equipment

• Pamasol
• • Hand and Vacuum Crimper
  • Single Stage Pressure Filler
  • Tandem Diaphragm Recirculating Pump
• Custom pMDI Cold Filling System
• Virtis IQ2 Cyclone High Shear mixer
• Turbula T2F Powder Blending System
• Propellant Pressure Burette
• Impulse AIE405 Heat Sealer

• Capillary electrophoresis: CZE, CGE, CIEF:
  • Detection: UV and LIF
• Gel electrophoresis: SDS-PAGE, Native PAGE, IEF and Agarose Gel
• Phast electrophoresis
• ELISA
• HPLC: RP, SEC, HIC, IEX, HAC and affinity (metal and Dye) modes:
  • Detection: UV/Vis, PDA, RI, ELSD, MS and Fl
• Peptide mapping: HPLC and LC/MS/MS
• Amino acid analysis (AAA)
• Carbohydrate analysis and glycosylation:
  • Colorimetric, CE and PDA
• Enzyme activity analysis
• Residual protein and chemical analysis
• Antibiotics, chelators, PEG and host cell protein
• Gel filtration
• Protein content
• UV, fluorometry, colorimetric and AAA
• Disulfide bonds
• Extinction coefficients
• MALS: Wyatt Technology Mini Dawn:
  • Protein-protein interaction
  • Protein aggregation
  • Stoichiometry of protein-protein complexes
• Semi Prep-LC
• Blotting, including:
  • Western
  • Northern
  • Southern

Stability Storage Facility

• Over 60,000 cu. ft. of both walk-in and reach-in stability storage space at three geographic locations
• Calibration, validation and preventative maintenance of equipment and stability chambers
• Customized computerized sample tracking tool monitored by computerized alarm system
• Chamber condition limit alarm with automatic telephone call out to staff (24/7)
• Full generator backup
• Standard chamber conditions include:
  • Ultracold (<-65 C)
  • -15 and -20 C
  • 5°C
  • 25°C/40% RH
  • 25°C/60% RH
  • 25°C/75% RH
  • 30°C/40% RH
  • 30°C/60% RH
  • 30°C/65% RH
  • 40°C/15% RH
  • 40°C/75% RH
  • Customized conditions upon request
  • Photostability chamber with white (visible) and near UV (UV-A) exposure options