Biopharmaceutical Development

Full Range Support for Biomolecules

  • Nucleic acids and oligonucleotides
  • Monoclonal antibodies
  • Vaccines
  • Peptides
  • Natural and recombinant proteins
  • Carbohydrates

From proof of concept to commercialization, depend on the scientific strength of Irvine. We offer reliable technical expertise, rigorous quality systems, state-of-the-art instrumentation, and thorough experience working with a range of biomolecules. What’s more, we maintain focus on the leading edge of science, service, and seamless collaboration.

Irvine provides a broad range of services including but not limited to the method transfer, method development and validation, drug substance/drug product release, stability, process and product related impurity analysis, leachable and contaminants, and investigational support for large molecules programs. Our customer service oriented project management team can help leverage your supply chain capabilities and improve project efficiencies to reduce time to market.

Comprehensive Biopharmaceutical Support

  • Cell-based bioassays
  • Western blot
  • Residual host cell protein and residual chemical analyses
  • Residual DNA analysis
  • Amino acid analysis (AAA USP <1052>)
  • Gel electrophoresis
  • Capillary electrophoresis: GCE, CZE, cIEF
  • Glycan analysis
  • Isoelectric focusing (IEF)
  • Peptide mapping (USP <1055>)
  • Protein content (strength)
  • HPLC (RP, SEC, HIC, IEX and mixed mode)
  • Surfactant analysis
  • Sugar analysis

Reliable Product Characterization

  • Identity by Amino Acid Analysis
  • Protein content (strength)
  • Peptide mapping by LC-MS
  • Immunoassays
  • Residual DNA analysis
  • Purity/Potency
  • Glycosylation analysis
  • Functional analysis
  • Process and product related impurity analysis
  • Disulfide bonds: Thannhauser method
  • Determination of extinction coefficients
  • Stability studies LTSS, Market Life, ICH

State-of-the-Art Instrumentation

  • Fast Real-Time PCR: Applied Biosystems 7500 (QPCR)
  • iCE3 Capillary: Protein Simple
  • Fast Resolution Chromatography: Agilent 1290
  • HPLC: Waters, Agilent, Dionex
  • HPLC Detection: UV/VIS, PDA ELSD, CAD, RI, FL
  • Ion Chromatograph: Dionex
  • Electrophoresis modules
  • Capillary electrophoresis:
    Beckman Proteomelab™ PA 8000
  • ELISA: BioTek
  • ELISA: molecular devices
  • Ultra-centrifuge: Beckman
  • UV transilluminator: BIO-RAD
  • Post column amino acid derivatization system: Pickering

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