Benefits of Spray Drying

  • Widely accepted platform technology
  • Particles engineered for multiple routes of delivery
  • Bioavailability enhancement of poorly soluble drugs (BCS Class II and IV)
  • Amorphous dispersions
  • Continuous process
  • Proof of Concept (POC) through Phase II clinical production
  • Milligrams to hundreds of kilograms
  • Reproducible and scalable
  • Organic-based solvents
  • Potent compound processing (Safebridge Category 3/OELs down to 30ng/m^3)
  • Spray from aqueous or organic solvents
  • Develop multiple formulations with grams of API
  • Readily accepted by regulatory authorities (FDA, EMA, etc.)

CritiTech's Spray Drying Equipment

  • Custom manufactured by Cotter Brothers, 316 stainless steel, with proven capability of producing Development through cGMP Phase III clinical trial materials
  • Development unit (SD30-analogous to Buchi 290)
    • Nominal drying gas rate : 40 – 100 kg/h
    • mgs to tens of kilograms – DCM throughput up to 10 kg/hr
    • Scaled to SD300
  • cGMP Phase II (SD100-analogous to GEA Niro PSD-1 Mobile Minor™)
    • Nominal drying gas rate : 40 – 100+ kg/h
    • Two separate units at CritiTech
  • cGMP Manufacturing (SD300-analogous to GEA Niro PSD-3)
    • Nominal drying gas rate : up to 600 kg/h

A variety of spray drying nozzles can be utilized in our SD units.

 

CritiTech's Spray Drying Facilities

Customers may reserve production suites now

  • July 1st, 2017 – Proof of Concept unit operational
  • October 1st, 2017 – First cGMP unit operational
  • January 1st, 2018
    • Expansion facility completed – 3 production suites
    • Second cGMP unit operational
    • Commercial scale unit installation ready