Analytical Services
Analytical Team Experience
Our team’s experience and flexibility in phase-appropriate Analytical Services result in timely and efficient clinical drug development. Althea’s analytical scientists are a highly seasoned team with proven track records in the biopharmaceutical industry. Our scientists have pioneered new applications of biochemical and biophysical analyses for the characterization of many different protein drugs.
Over the last 30 years, our analytics group has shown a successful track record of working closely with regulatory agencies worldwide. The team has been involved with submissions of many of the top commercial drug product successes.
Analytical CapabilitiesOn-site laboratories are equipped with sophisticated analytical instrumentation, enabling scientists to employ a full range of methodologies and techniques to characterize your product and develop test methods that will validate your product’s integrity throughout its life cycle. All laboratory instrumentation is either on a manufacturer’s calibration program or an equipment validation program.
Primary Structure Analysis- Peptide mapping via UV-HPLC or LC/MS/MS (QTOF, Ion Trap)
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Peptide sequencing via LC/MS/MS (QTOF, Ion Trap)
Biophysical Characterization- Multi-angle light scattering (MALS)
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Circular dichroism (CD)
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Fourier-Transform infrared spectroscopy (FTIR)
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Differential scanning calorimetry (DSC)
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Dynamic light scattering (DLS)
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Second-derivative UV spectroscopy
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UV/VIS spectroscopy
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Electrophoretic mobility (Zeta-potential)
Glycan Analysis- Monosaccharide composition
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Oligosaccharide mapping
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Sialic acid quantitation
HPLC- Size-exclusion chromatography
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Ion-exchange chromatography
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Affinity-based chromatography
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Reversed-phase chromatography
Capillary & Conventional Gel Electrophoresis- Capillary isoelectric focusing (cIEF)
SDS-PAGE
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Western blot
Process Residuals- ELISA
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qPCR
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HPLC (antibiotics, IPTG, surfactants, etc.)
Potency Assays- Enzymatic activity assays
Particulate Analysis, Including Sub-10 Micron Particle Characterization- Microscopic-flow imaging (MFI)
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Asymmetric-flow field flow fractionation (A4F)
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Sub-10 micron particle characterization
Mass Spectrometry (QTOF, Ion Trap)- Intact mass
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Disulfide mapping
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PEGylation site identification
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Peptide mapping with LC/MS or LC/MS/MS
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Identify post translational modifications (oxidation, deamidation)
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Glycan characterization & linkage-site identification