Biopharmaceutical Development

Supporting start-ups to globally recognized biotech companies, Irvine has the track record and knowledge to provide comprehensive support for biomolecules at all phases.

Partner with Irvine's Biopharmaceutical Development Team

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 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.

At Irvine our mission is to provide our clients with outsourcing solutions that make their drug development and commercialization priorities possible.

Full Range Testing of Biomolecules

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

Comprehensive Biopharmaceutical Support

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

Product Characterization Expertise

  • Identity by Amino Acid Analysis
  • Protein content
  • 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

State-of-the-Art Instrumentation

  • Fast Real-Time PCR: Applied Biosystems 7500 (QPCR)
  • iCE3 Capillary: Protein Simple
  • Fast Resolution Chromatography: Agilent 1290
  • UPLC
  • LC/MS/MS
  • Agarose and cellulose acetate (flatbed chambers)
  • HPLC: Waters, Agilent, Dionex (UV/Vis, PDA, RI, FL, CAD, ELSD, ES)
  • Ion Chromatograph: Dionex
  • Capillary electrophoresis:
    Beckman Proteomelab™ PA 8000
  • SDS-Page (multiple formats)
  • Immunoblot (multiple formats)
  • Solo VPE
  • Biotek Synergy
  • HT Microplate Reader
  • Biotek ELx405 Microplate Washer
  • Ultra-centrifuge: Beckman
  • UV transilluminator: BIO-RAD
  • Post column amino acid derivatization system: Pickering
  • UV/VIS Spectrophometer Agilent

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