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Drug Manufacturing at BioDuro

Drug Product Manufacturing

cGMP manufacturing of drug product through Phase II. Excellence in manufacturing that ensures quality products.

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Overview

Capable of manufacturing solid, liquid, and semi-solid dosage forms, BioDuro’s Drug Product Manufacturing team provides a comprehensive service for clinical trial material preparation in support of Phase 0 to Phase II studies. Our contract pharmaceutical manufacturing services are cGMP compliant and include established clinical trial material management SOPs with QA oversight. Our highly trained manufacturing team is dedicated to on time delivery of high quality product. We believe that having a well trained and experienced manufacturing staff will streamline manufacturing efficiency and increase process reliability, positively impacting project timelines. Whatever your project, our expert staff will ensure its successful completion.

BioDuro Advantage

  • Flexible manufacturing scheduling
  • Well trained and experienced manufacturing operators
  • Full project management transparency during production
  • Strong QA oversight

Dosage Forms

  • Tablets
    • Immediate release tablets
    • Coated tablets
    • Matrix tablets
  • Capsules
    • Blend in capsules
    • Tablets in capsules
    • Liquid in capsules
    • API in a capsule (Xcelodose®)
    • Pellets in capsule
  • Beads, Pellets and Granules
    • Coated pellets/beads
    • Controlled release beads
  • Oral Liquids
    • Liquids
    • Suspensions
    • Lipid-based delivery systems
  • Topical
    • Creams
    • Gels
    • Ointments

Process Technologies

  • Hot Melt Extrusion
    • Leistritz ZSE-18mm Twin Screw Extruder
    • Leistritz Nano-16mm Twin Screw Extruder
    • Thermo Fisher Haake MiniLab II Micro Compounder
    • Scheer Bay BT 25 Pelletizer
  • Spray Dried Dispersion
    • Buchi Nano Spray Dryer B-90 HP
    • Buchi Mini Spray Dryer B-290
    • SPX Anhydro MicraSpray 35
    • SPX Anhydro MicraSpray 150
  • Roller Compaction
    • Gerteis Mini-Pactor
  • Wet Granulation
    • Granumeist High Shear Granulator
  • Milling
    • Fitzpatrick L1A Fitzmill
    • Fitzpatrick DASO-6 Fitzmill
    • Hosokawa 50 AS Spiral Jet Mill
    • Quadro Comil Model 197
    • Glen Mills DynoMill
  • Blending
    • Bohle Bin Blender
    • Patterson-Kelly V-Shell Blender
  • Tablet Compression
    • Stokes B2 16-station Rotary Tablet Press
    • Manesty Express
    • Korsch XL-100 Single-Sided Rotary Tablet Press (2)
    • Globe Pharma Manual Tablet Compaction Machine
    • Key International Tablet Deduster
    • Safeline Tablex Metal Detector
  • Encapsulation
    • Capsugel Xcelodose 600S
    • Torpac Profill 1100
    • PAM Pharmaceutical AF40T Capsule Filler
    • Dott Bonapace IN-CAP Encapsulator
  • Pan Coating
    • Freund-Vector LDCS Pilot Hi-Coater
    • Freund-Vector LDCS-3 Hi-Coater
  • Wurster Coating
  • Spray Granulation
  • Fluid Bed Drying
    • Glatt GPCG2 Fluidized Bed, Mini-Glatt

Packaging Capabilities

  • Drum Storage
  • Induction Sealed Bottles (Child Resistant Closures)
  • Automated Tablet/Capsule Counting
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