Validated capability from Product Development to GMP-approved Commercial Manufacturing

Research and Development

  • Dedicated GMP Development Laboratory
  • Additional Non-GMP Small Scale Laboratory
  • Integrated R&D validated through to commercial manufacturing
  • Full-service capabilities for even the most complex product creation
  • In-house regulatory affairs team with proven global track record
  • Flexible Business Model customized to fit your program

Capabilities

  • Pre-formulation
  • Formulation development
  • Support including physical characterization
  • Analytical Method Development & Validation
  • IMPD Manufacture and QP release
  • Tech Transfer
  • ICH stability programs at all conditions
  • Efficient product development pathways for ANDA, 505(b)(2), IND/NDAs, and novel delivery systems
  • Preclinical to clinical to commercial capability
  • IVIVC-based modified release dosage form development

Precision Particle Fabrication®

One such novel drug-delivery system is Adare’s Precision Particle Fabrication® technology, which produces uniform microspheres and microcapsules offering precise control over particle structure.

Small-Scale Non-GMP Laboratory

Customizable, flexible systems to expedite formulation and process development services
  • Small-scale non-GMP lab supports existing GMP development laboratory capabilities
  • Provides additional early-stage non-GMP development capacity
  • Produce smaller batches using less active pharmaceutical ingredients (APIs).
  • Mirror’s Adare’s pilot and production capabilities
  • Start projects immediately
  • Faster development timelines
Additional Non-GMP Capabilities:
  • Microencapsulation
  • Roller-compaction dry granulation
  • Capsule Filling
  • Wet granulation (aqueous and solvent)
  • Milling
  • Blending
  • Tablet compression
  • Fluid Bed Processing
    • Wurster Coating
    • Top Spray Granulation
Equipment
  • Riva Piccola Tablet Press
  • Glatt Mini Fluid Bed
  • Dott Bonapace Capsule Filler
  • Key KG-5 High-Shear Granulator
  • Fluid Air Granumil Jr. Mill
  • PK-Blend Master
  • Comil Quadro B-97
  • Fitzpatric IR 220 Chilsonator
  • Fitzmil L1A
  • Availability of all Required Physical Testing Equipment
Classified to Process Organic Solvents
Vector VFG-1 Features:
  • Running Acetone, IPA, and Ethanol
  • Wurster Bottom Spray Coating
    • 6” Wurster (700-200 g)
    • 4” Wurster (400-800 g) future addition
  • Top Spray Capable
  • 1 Liter Microcap Reactor
    • Approximate Batch Size
    • Range 40-200 g.

Speak With An Expert

Profile Photo: Giovanni Ortenzi

Giovanni Ortenzi

Vice President, Pharmaceutical Development & Chief Technical Officer

Giovanni leads our global pharmaceutical development, technical services and operational excellence teams. He was previously Vice President, Quality at Adare leading quality assurance, quality control, clinical quality assurance and compliance teams. Prior to that, he led the quality teams at Aptalis Pharmaceutical Technologies. Giovanni held leading positions at Eurand, including Industrial Operations Director–Europe. He also formerly held quality and manufacturing positions with Bristol-Myers Squibb.

Giovanni holds degrees in Pharmaceutical Chemistry and Pharmacy from the University La Sapienza in Rome, Italy.

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