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.


  • 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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Our project management team serves you better

Our signature service assigns you a single, dependable point of contact who guarantees all of the benefits of valued partnership such as strategic planning meetings, weekly reports, high quality data, and detailed post-project follow-up.

We invite you to visit us, audit our facilities, discover our insight, and learn more about our commitment to excellence. Contact us or call 877-445-6554.

Irvine's complete package of services include:

Parenteral Manufacturing (Avrio)

  • Process Validation
  • Lyophilization
  • Scale-Up Studies

Formulation Development (Avrio)

  • Formulation Characterization
  • Container/Closure Compatibility Studies

Analytical Chemistry

  • USP/NF, EP, BP, JP, ACS, AOAC, and Client Methods

Analytical Development

  • Method Development and Validation
  • Process Validation Support
  • Cleaning Validation and Verification
  • Comparator Studies and Reference Standard Qualification


  • Method Development and Validation
  • Product Characterization and Quality Control Testing

Drug Delivery Technologies

  • Inhalation/Nasal Product Testing
  • Transdermal Product Testing
  • Device Evaluation


  • Quality Control Testing
  • Research and Development

Stability Storage

  • Standard ICH and Custom Storage Conditions

Structural Chemistry

  • Extractable/Leachables
  • Reference Standard Characterization
  • Structural Elucidation of Unknowns
  • Investigational Studies