HPLC

  • Agilent 1100 and 1200 Series Chromatography Systems
  • Detectors: UV, RI, Diode Array, Light Scattering, MS

HPLC is commonly used for identifying and/or quantifying compounds, impurity levels, and for purity determination especially as testing for storage stability studies. Methods commonly developed for size exclusion chromatography (SEC), ion exchenge chromatography (IEX), and reversed and normal phase chromatography.

LC/MS/MS

  • Two AB SciEx API 4000 Triple Quadrupole Mass Spectrometers (LC/MS/MS)

The triple quads are commonly used for drug and biomarker analysis in PK studies and low level residue analysis (detergents, reagent impurities) in complex matrices.

  • Sciex 5600 Triple TOF (Time-Of-Flight) LC/MS

The TOF is commonly used for chemical characterization in leachable and extractables studies, identifying unknown impurities (good lot vs bad lot) and protein identification (intact mass determination and peptide digest).

GC

  • Agilent 6850 with Flame Ionization Detector (FID)

The GC is commonly used for residual solvent analysis (with and without headspace injector), compound quantification.

GC/MS

  • Agilent Technologies GC/MS with headspace

The GC/MS is commonly used for chemical characterization in leachable and extractables studies, compound quantification (pesticide, phthalates, methyl methacrylate, glycerol, nicotine).

ICP-MS

  • Agilent 7700x

ICP/MS is commonly used for heavy metal analysis as applied to raw material screening or lot release. Chemical characterization in leachable and extractables studies often requires elemental analysis using ICP/MS.

Gel Analysis and Imaging

  • Bio-Rad Criterion Gel System
  • Bio-Rad Gel Doc EZ
  • Bio-Rad Experion System
  • Serva Blue Horizon IEF System
  • Bio-Rad Trans Bolt Turbo Transfer System

Gel analysis and imaging are used for protein identity tests and determining protein purity.

ELISA and Activity Assays

  • Molecular Devices SpectraMax 384 Plus (2 total)
  • BioTek FL/Luminescence FLx800
  • BioTek UV/Vis ELx808

ELISA and Acitivty Assays are comonly used for immunogenicity testing and PK analysis in biological matrices, and affinity analysis of antibodies and/or receptors.

Laser Light Scattering with UV and RI (Static)

  • Wyatt Minidawn

UV/Vis Spectroscopy is commonly used for molecular weight determination for large molecular weight polymers, proteins, or fusion proteins. Typically this technique is paired with HPLC using size exclusion chromatography (SEC).

FTIR

  • Cary 630

FTIR is comonly used for chemical characterization of oils, polymers and plastic- or rubber-based materials.

Moisture Content

  • Mettler C20 Coulometric KF Titrator

Karl Fischer moisture content analysis is commonly used for determining the residual water content in drug substances, drug products, and similar solid and liquid products.

UV/Vis

  • HP 8453

UV/Vis Spectroscopy is commonly used for determining the the determination of protein content, and rough identification of specific compounds and potential contaminants.

Polarimetry

  • JASCO P-2000

Osmometer

  • Advanced Micro-Oscmometer Model 3320

Viscosity

  • The Brookfield RVDV-II +Pro Viscometer

pH

  • Orion 420A
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