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Small Molecule Solutions

Testing capabilities

  • Chromatography / Electrophoresis

    • HPLC & UPLC (UV/DAD/CAD/MS/ELSD/FLD)

    • Gas chromatography (GC)

      • liquid & headspace

      • FID & TCD

    • Capillary Electrophoresis (CE)

  • Mass Spectrometry

    • LC-MS Single Quad

    • HR-MS

  • Spectroscopy

    • FT-IR
    • UV-VIS

  • Physico chemicaltesting

    • XRD

    • Differential Scanning Calorimetry (DSC)

    • Particulate matter

    • Hardness

    • Disintegration

    • Friability

  • Dissolution

    • USP type 1 (baskets)

    • USP type 2 (paddles)

    • QC (real-time & accelerated)

    • Biorelevant

  • Wet chemistry

    • Osmolality

    • Solubility

    • pH

    • Density

    • Viscosity

    • Appearance

    • Heavy metals

    • Sulphated ash

    • Titration

  • Water content

    • Karl Fisher

      • Volumetric

      • Coulometric (with/without VAP)

    • Water activity

  • Contaminants

    • Microbiology (outsourced)

    • Endotoxines

  • Potency

    • Immuno assays

    • Enzymatic assays

    • Cell-based assays

Technologies

  • Karl Fischer titration

  • Spectophotometry

  • USP type 1 (baskets)

  • Viscosity

  • Liquid Chromatography

  • USP type 2 (paddles)

  • Density

  • Gas Chromatography

  • Osmometry

  • Mass Spectrometry

  • XRD

  1. LC-MS, Single Quad

  • Capillary Electrophoresis

  1. LC-MS, High Resolution

  • Karl Fischer titration

  • Viscosity

  • Density

  • Spectophotometry

  • Liquid Chromatography

  • Gas Chromatography

  • USP type 1 (baskets)

  • USP type 2 (paddles)

  • Osmometry

  • XRD

  • Capillary Electrophoresis

  • Mass Spectrometry

    • LC-MS, Single Quad

    • LC-MS, High Resolution

Biologics Solutions

Testing capabilities

  • Quantity

    • Total protein content
    • In matrix (serum, CSF)

  • Identity & purity

    • Molecular weight

    • Size distribution

    • Charge variants

    • Glycosylation profile

    • Disulfide bridges

    • Drug-to-antibody ratio (DAR)

  • Impurities

    • Degradation

    • Physical / Chemical modifications

  • Potency

    • Immuno assays

    • Enzymatic assays

    • Cell-based assays

  • General quality

    • Appearance

    • pH

    • Osmolality

    • Particulate matter

    • Moisture content

  • Process impurities & contaminants

    • Host-derived (HCPs, DNA)

    • Downstream / culture-derived

    • Residual solvents / chemicals / biochemicals / inorganic salts

    • Medium components

    • Mycoplasma

    • Sterility (outsourced)

    • Endotoxins

Technologies

  • Karl Fischer titration

  • Spectophotometry

  • Real-time PCR (RT-qPCR)

  • Viscosity

  • Liquid Chromatography

  • Luminescence/Fluorescence

  • Density

  • Gas Chromatography

  • ELISA

  • Osmometry

  • Gel Electrophoresis

  • Mass Spectrometry

  • Light Obscuration

  • Chip Electrophoresis

  1. LC-MS, Single Quad

  • Laser Diffraction

  • Capillary Electrophoresis

  1. LC-MS, High Resolution

  • Dynamic Light Scattering

  • Flow Imaging Analysis

  • Karl Fischer titration

  • Viscosity

  • Density

  • Osmometry

  • Spectophotometry

  • Liquid Chromatography

  • Gas Chromatography

  • Real-time PCR (RT-qPCR)

  • Luminescence/Fluorescence

  • ELISA

  • Gel Electrophoresis

  • Chip Electrophoresis

  • Capillary Electrophoresis

  • Light Obscuration

  • Laser Diffraction

  • Dynamic Light Scattering

  • Flow Imaging Analysis

  • Mass Spectrometry

    • LC-MS, Single Quad

    • LC-MS, High Resolution

Cell & Gene Therapy Solutions

Testing capabilities

  • Characterization

    • Multiplex testing / FACS

    • Primer & probe design

    • Electrochemiluminescence (MSD)

  • Identity

    • Single/ multiple protein markers

    • Absence of marker(s)

    • Protein secretion

    • Gene expression

    • Distribution by flow cytometry

  • Purity

    • Percentage of dead cells & undesired cells

    • Ratio viability

    • MHCII

  • Potency

    • Biomarkes

    • ELISA

    • Gene expression by RT-qPCR

    • Enzymatic assays

    • Cell-based assays

    • Flow cytometry

    • Mixed lymphocyte reaction

    • (MLR) assay

  • Quantity

    • Cell viability

    • Cell count

  • General quality

    • Appearance

    • pH

    • Osmolality

  • Process related impurities & contaminants

    • Host-derived

    • (HCPs, DNA)

    • Downstream/ cultured-derived

    • Residual solvents/ chemicals/ biochemical/ inorganic salts

    • Medium components

    • Mycoplasma

    • Sterility (outsourced)

    • Endotoxins

Technologies

  • Cell Culture

  • Capillary electrophoresis

  • Gas Chromatography

  • Electroporation

  • Real-time PCR (RT-qPCR)

  • Liquid Chromatography

  • Flow Cytometry

  • Luminescence/Fluorescence

  • Spectrophotometry

  • ELISA

  • Meso Scale Discovery's (MSD)

    Multi Array technology

  • High-Resolution Mass Spectrometry

  • Cell Culture

  • Electroporation

  • Flow Cytometry

  • ELISA

  • Capillary electrophoresis

  • Real-time PCR (RT-qPCR)

  • Luminescence/Fluorescence

  • Meso Scale Discovery's (MSD); Multi Array technology

  • Gas Chromatography

  • Liquid Chromatography

  • Spectrophotometry

  • High-Resolution Mass Spectrometry

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