Medicago New Influenza Vaccine Facility, QC

Medicago Facility

Medicago's new multi-million dollar QC complex for pandemic flu, new vaccines, monoclonal antibodies and other protein based therapeutics.

Our Scope
Custom design, project development and integration of process critical infrastructure and all upstream and downstream processing equipment for the commercial and pilot plant facility.

Services Provided:

Process Engineering Commissioning And Qualification Validation Compliance and Start up

Project Scope

  • Process definition and characterization
  • Scale-up assessment
  • Scaled-up process design for tech transfer
  • Complete process design from extraction to final formulation
  • Full process integration into facility design Utility loads and integration
    Process architectural flows
    Production scheduling (SchedulePro®)
    Process Simulations (SuperPro®)
    Process HAZOP
  • Process Qualification

    GMP risk assessment
    FAT to IOQ

Equipment Image

Design Scope

  • Buffer preparation, storage and distribution
  • Biomass extraction units
  • Microbial fermentation trains
  • Upstream biomass coarse separation, centrifugation and depth filtration train
  • Downstream tangential flow filtration, UV inactivation and chromatography purification trains
  • Flammable solvent processing, storage and recovery
  • Biosafety containment and laminar flow booths
  • Single-use system (SUS) and hybrid single-use systems
  • Aqueous and solvent based Clean-in-place (CIP)
  • Steam-in-place (SIP) and Clean-out-place (COP)
  • USP Purified Water and Water for Injection FRS
  • Temperature Control Units (TCUs)
  • Autoclaves and parts washers
  • GAMP compliant process instrumentation and automation