Analytical Development Services

Keeping you on-point, on-track, and on-spec

A High-Performance Partner to Help Execute Your Product Process Development

Emergent CDMO offers the technical capability, experienced personnel, equipment resources, and demonstrated expertise to support the development and understanding of your product with a full range of characterization methodologies and assay development.

  • Technology transfer
  • Method development
  • Optimization, feasibility, and robustness studies
  • Development of bio-immuno and complex potency assays
  • Method qualification and validation
  • Release and stability testing through Phase 3
  • Drug substance and drug product characterization testing
  • Validation and characterization testing to support IND and BLA/ANDA submissions
  • Regular investments in the latest process development technologies and equipment

With more than 20 years of process development experience, Emergent CDMO provides its clients with distinct advantages for their biological programs:

  • Proteins (recombinant, plasma, fusion)
  • Antibody (mAb, pAb, antibody fragments)
  • Viral platforms
  • Viral vectors
  • Recombinant viruses
  • Gene therapy
  • Enzymes
  • Nanoparticle platforms
  • Peptides

Technologies and Capabilities to Advance Your Program to the Next Level

 

Chemical Capabilities Biochemical Capabilities Stability Testing Conditions
  • SEC HPLC/UPLC
  • RP HPLC
  • IEX HPLC
  • LC-MS
  • Peptide mapping
  • Oligosaccharide profiling
  • Amino acid analysis
  • FTIR
  • JESS
  • ELISA (titer and impurity)
  • SDS-PAGE and CE SDS
  • Western blotting
  • Total Protein
  • Compendial testing
  • Agarose Gel Electrophoresis
  • PCR, qPCR, and RT-qPCR
  • Potency assays
  • Viral infectivity
  • Routine cell culture capabilities
  • UV-Vis and Fluorescence Spectrophotometry
  • BLI
  • -65 °C and below
  • -40 °C
  • -20 °C
  • -5 °C
  • -25 ˚C
  • -40 ˚C

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