Biopharmaceutical Services

Supporting the growing number of biotechnology-derived therapeutic agents

Supporting the growing number of biotechnology-derived therapeutic agents

Alcami offers a broad range of biopharmaceutical analytical services to support the growing number of biotechnology-derived therapeutic agents. Having over 20 years of biopharmaceutical experience, the Alcami scientists are equipped with the technology and armed with expertise to support a wide variety of biopharmaceutical and biologic products, including peptides, proteins, antibodies, antibody drug conjugates (ADC), oligosaccharides, and nucleic acids.

Alcami has full analytical testing abilities including determining the purity, the activity, and the characterization of biologics. Alcami can also perform the formulation development being equipped with parenteral manufacturing capabilities and lyophilization capabilities.

Alcami’s biopharmaceutical services include:

Structural Chemistry

  • Biopharmaceutical structural characterization
  • Oligosaccharide analysis
  • Accurate mass determination
  • Biosimilar characterization

Bioassay

  • Method development and validation for Biopharmaceutical Active Pharmaceutical Ingredient (API) and finished product
  • Bioactivity testing
  • Potency
  • Protein concentration

Purity

  • Method development and validation for Biopharmaceutical Active Pharmaceutical Ingredient (API) and finished product
  • Chromatography
  • Routine peptide mapping
  • Amino Acid Analysis (AAA)
  • N-terminal sequencing by Edman sequence
  • Oligonucleotide analysis
  • Purity assessment by Electrophoresis
  • Imaging Capillary Isoelectric Focusing (iCE)
  • Western blot

Biosafety

  • Host cell residual protein
    • ELISA
  • Residual DNA residue testing
    • Threshold system
  • Aggregation, particulates and agglomerate analysis
    • Size exclusion chromatography
    • Micro fluid imaging
  • Quantitate residual components
    • Residual buffers
    • Residual anti-foam compounds
    • Residual antibiotics

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