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Method Development >> Characterization >> Physico-Chemical Characterization of Biopharmaceutical Products

Physico-Chemical Characterization of Biopharmaceutical Products

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Orbitrap Fusion Lumos InstrumentCharacterization testing is utilized to gain an understanding of the physical and chemical properties of biopharmaceutical materials. During process and drug development, these properties can have an impact on the product’s performance, ability to be processed, stability and appearance. Therefore, a well characterized biopharmaceutical is integral to moving a candidate through development and to the market. Due to the complex nature of these materials, extensive testing utilizing a wide array of techniques is required.

Eurofins BioPharma Product Testing provides cGMP compliant characterization testing according to regulatory guidelines for biopharmaceutical products to support formulation or process development, biosimilar development, quality control, cGMP lot release testing, and investigational manufacturing troubleshooting.

Why Choose Eurofins BioPharma Product Testing?

  • Our extensive experience with a variety of techniques and sample types lends the ability to tailor the testing to meet specific client requirements at one testing location.
  • We utilize software such as Protein Metrics, Protein Discoverer, and BioPharmaFinder to support the characterization workflow and enhance all mass spectral techniques.
  • We can perform client provided methods, as well as, develop new methods when no current method exists.

Experience

  • Therapeutic Proteins
  • Monoclonal Antibodies
  • Vaccines
  • Biosimilars
  • Conjugates
  • Antibody-Drug Conjugates (ADCs)
  • Peptides
  • Enzymes
  • Fusion Proteins
  • Virus-like Particle (VLP)

Characterization Testing Capabilities

Chromatography

  • Purity/Impurities by RP-HPLC, SEC, IEX
  • Amino Acid Analysis (UPLC)
  • Glycan Analysis by HILIC-Fluorescence
  • Free Thiol Analysis (Ellman’s)
  • Aggregation (SEC)
  • Excipient Content
  • Peptide Mapping (UV profile)

Electrophoresis

  • Purity/Impurities by Molecular Weight (CE-SDS, CE-LIF, SDS-PAGE, Native-PAGE)
  • Charged Isoform Profile (icIEF, IEF)
  • Anion/Cation Identification (CZE)

Spectroscopy

  • Protein Concentration (UV-VIS by A280, SoloVPE)
  • Extinction Co-efficient Determination
  • Excipient Residual or Content (UV, Fluorescence)
  • Higher Order Structure (CD)
  • UV, IR, Fluorescence
  • Sub-visible Particulates (MFI)

Compendial

  • pH
  • Appearance
  • Osmolarity/Osmolality (Freezing point or Vapor Pressure)
  • Volume in Container and Extractable Volume

Mass Spectrometry

  • Peptide mapping including:
    • Confirmation of amino acid sequence and coverage
    • Post translational Modifications
    • Disulfide bond mapping
  • Mass Analysis including:
    • Intact proteins, subunits (reduced form), and domains (IdeS enzyme)
    • Glycosylated and deglycosylated proteins
    • Identification and relative quantitation of isoforms and glycoforms
    • ADCs Drug to Antibody Ratio (DAR) calculation
    • Proteins and pegylated proteins by MALDI TOFMS
  • Miscellaneous Proteomic Techniques
    • Fraction collection and identification of unknown peaks
    • NanoLC and Nanospray capabilities
    • Identification and quantitation of Host cell proteins (HCP)
    • In-Gel Digestion of SDS-Page Bands
    • Bioanalysis of protein mixtures and database searching

MS Instrumentation

  • LTQ/Orbitraps
  • Lumos Orbitrap
  • ESI TOF Mass Spectrometers
  • Bruker MALDI TOF
  • Triple Quadrupoles
Data from Lumos Orbitrap

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