Drug Product Development Services

Designed to sync seamlessly with your specific needs

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

Emergent CDMO offers the technical capability, experienced personnel, equipment resources, and demonstrated expertise to develop cGMP-compliant formulation processes that preserve product quality.

  • Formulation screening, selection, and optimization
  • Forced degradation and excipient screening studies
  • Drug product characterization
  • Down-selection of liquid versus lyophilization
  • Lyophilization cycle development
  • Dosage form, container closure, and device selection
  • Phase-appropriate analytical services
  • Stability testing under a wide range of conditions
  • Support for toxicity and other IND-enabling studies
  • 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)
  • Antibodies (mAb, pAb, antibody fragments)
  • Viral platforms (live and live-attenuated)
  • Vaccines
  • Recombinant viruses 
  • Gene therapy
  • Enzymes
  • Nanoparticle platforms, including lipid nanoparticles (LNPs)
  • Peptides

Technologies and Capabilities to Advance Your Program to the Next Level

Formulation Development Lyophilization Drug Product Characterization
  • Tank/vessel design
  • Single-use, disposable system for aseptic formulation
  • Mixing studies
  • Order-of-addition studies
  • Filtration process development
  • Process scale-up and optimization
  • Thermal characterization
  • Lyophilization cycle optimization
  • Optimization of product quality
  • Development of lot-production and non-cGMP stability
  • Particle-size distribution
  • Morphology
  • Number density and particulate identification
  • Zeta potential
  • Particulate investigation
  • Protein and virus size and charge 
  • Protein structure

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