HPLC
- Agilent UPLC 1290 Infinity II
- Agilent 1290, 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 exchange chromatography (IEX), and reversed and normal phase chromatography.
LC/MS/MS
- SCIEX Triple Quad 6500+ LC/MS/MS
- Two AB SCIEX API 4000 Triple Quadrupole Mass Spectrometers (LC/MS/MS)
- SCIEX 5600 Triple TOF (Time-Of-Flight) LC/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.
The TOF is commonly used for chemical characterization in extractables and leachables studies, identifying unknown impurities (good lot vs bad lot) and protein identification (intact mass determination and peptide digest).
TOF/MS
- SCIEX TripleTOF 5600 High Resolution Mass Spec
The tripleTOF mass specs are commonly used for extractable leachable medical device and USP <661> testing as well as metabolite and protein analysis .
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 extractables and leachables 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 extractables and leachables 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 Activity Assays are commonly used for immunogenicity testing and PK analysis in biological matrices, and affinity analysis of antibodies and/or receptors.
MSD Assays
- Meso Scale Discovery (MSD) QuickPlex SQ 120
The QuickPlex instrument aids in the development of in vitro assays with high sensitivity and dynamic range, and low sample amount and reagent consumption. It can also handle multiplexed assays. The instrument uses electrochemiluminescence (ECL) detection technology.
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 commonly 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