Biopharmaceutical Services

 

    Your Dedicated Analytical Testing Partner for Biologics.

    Alcami offers a broad range of analytical services to support the growing number of biotechnology-derived therapeutic agents. With over 20 years of experience in biotherapeutic analytical development, Alcami scientists are equipped with the technology and armed with the expertise to support a wide variety of biotherapeutic products, including peptides, proteins, antibodies, antibody drug conjugates (ADC), and cell and gene therapies. 

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    Alcami Has You Covered with Analytical Support Throughout the Product Development Lifecycle

    • R&D / Preclinical / Ph1-2: Method Development, Structural Characterization, Release, and Stability
    • Ph3 / Commercial: Method Validation, Release, and Stability

    Alcami has a robust quality system and the right combination of expertise and equipment to establish the identity, purity, potency, and safety of your biotherapeutic product. Alcami can also perform formulation development and is equipped with parenteral manufacturing and lyophilization capabilities.

    Biosimilars
    Connect with us for your analytical characterization support and comparison studies to establish the biosimilarity of your molecule.

     Learn More About Alcami's Biopharmaceutical Services

    Structural Characterization and Confirmation
    • Amino acid sequence
      • N-terminal sequencing (Edman degradation)
      • Peptide mapping with LC/MS detection
    • Amino acid composition
      • Amino acid analysis
    • Disulfide bridges
      • Non-reducing peptide mapping with LC/MS detection
      • Post-column reduction peptide mapping with LC/MS detection
    • Carbohydrate structure
      • Glycosylation position using peptide mapping
      • Carbohydrate composition
      • Oligosaccharide pattern
    Physicochemical Properties
    • Molecular weight
      • Intact mass (mass spectrometry)
      • Size-exclusion chromatography (SEC)
      • SDS-PAGE (reduced and non-reduced)
    • Isoform pattern
      • Isoelectric focusing (IEF)
        • Traditional IEF
        • Imaged capillary (iCE)
      • Extinction coefficient (molar absorptivity)
        • Amino acid analysis
      • Electrophoretic patterns
        • SDS-PAGE (reduced and non-reduced)
        • IEF
        • Western blot
      • Liquid chromatographic patterns
        • SEC
        • Ion-exchange (IEX)
        • Reversed-phase (RP)
      • Spectroscopic profiles
        • UV-Vis
    Process-related Impurities
    • Host cell impurities
      • DNA (Threshold system)
      • Protein (ELISA)
      • Endotoxin
    • Fermentation and process-related impurities
      • Antibiotics
      • Antifoams
      • Buffers
      • Process reagents
    Product-related Impurities
    • Truncated forms
      • RP-HPLC
      • SDS-PAGE
      • Peptide mapping
    • Other modified forms
      • Peptide mapping
      • Chromatography
        • IEX
        • RP
      • CE or iCE
    • Aggregates
      • SEC
    Binding
    • ELISA
    • Western blot
    • Cell-based bioassays

    Biopharmaceutical Testing Services


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