Development

Microbial CDMO

• Research & Discovery

  • Strain Engineering

  • Strain Screening

  • Microbial Cell Banking

  • Tag-free Protein Preparation

  • Custom Plasmid Preparation

• Development

  • Microbial Cell Banking

  • Upstream Process Development

  • Downstream Process Development

  • Formulation Development

  • Pilot Scale Up

• Manufacturing

  • GMP Manufacturing for Clinical Supply

  • GMP Manufacturing for Commercial Supply

• Analysis and Testing

  • Microbial Cell Bank Characterization

  • Analysis Method Development

    • Protein Analysis Method Development
    • DNA Analysis Method Development

  • Quality Control

    • Quality Control of Protein
    • Quality Control of Plasmid DNA

  • Protein Structure Characterization

    • Protein Mass Analysis using LC-MS
    • Size Variant Analysis
    • Charge Variant Analysis
    • Peptide Mapping
    • Disulfide Bonds
    • Free Sulfhydryl Groups
    • N terminal Sequencing
    • C terminal Sequencing
    • Thermal Stability (Tm)
    • Amino Acid Deamidation
    • Amino Acid Isomerization
    • Amino Acid Oxidation
    • Extinction Coefficient
    • N-glycan Profiling
    • N-glycosylation Site Occupancy
    • N-Glycosylation Site

  • Stability Studies

• Regulatory Affairs

  • Regulatory Affairs

  • Regulatory Strategy Consulting

  • CMC Preparation (CTD)

  • IND or BLA application