Our
Capabilities

Our technical teams specialise in scalable, cost-driven manufacture of drug delivery devices, specifically for potent API applications. We employ moulding, solvent casting, extrusion, and co-extrusion processes, that are developed in our R&D labs, proven in our pilot GMP suites, and scaled in our GMP manufacturing facility.

Formulation
and Processing

  • Compounding (polymer/drug composite manufacture)
  • Batch mixing (30-50g scale)
  • Twin-screw extrusion (>500g scale)
  • Extrusion
  • Twin-screw extrusion (rod profiles)
  • Twin-screw co-extrusion (encapsulated rod profiles)
  • Moulding
  • Injection moulding
  • Compression moulding
  • Silicone and thermoplastic applications

Development
and Manufacture

  • DoE screening of moulded formulations
  • Process development
  • Analytical development
  • Pilot-scale GMP manufacture (up to 50kg batch scale)
  • Industrial-scale GMP manufacture (up to 600kg batch scale)
  • Packaging
  • Labelling
  • Large GMP warehouse

Analytics

  • R&D (flexible) and GLP (controlled) Quality teams
  • Raw material, in-process, and release testing
  • Image-based, automated QC measurement (Micro-Vu)
  • HPLC, UPLC, UV-Vis, FTIR, (chromatography/spectral analysis)
  • DSC (thermal analysis)
  • Polarised microscopy (materials and crystallisation analysis)
  • Dissolution with autosampling (drug release)
  • Sonication or soxhlet (content analysis)
  • Mechanical testing
  • Stability (intermediate and accelerated chambers)

Quality

  • GMP (pharmaceutical)
  • FDA registered, (currently supplying to >50 countries worldwide)
  • NIR in-process control
  • Quality by Design (QbD)
  • Dedicated Quality Control team
  • Dedicated Quality Assurance team
  • Equipment Qualification (IQ, OQ, PQ)
  • Process validation (process studies, gauge R&R, method validation)
  • Tool inspections and refurbishment
  • Root cause analysis (RCA, FMEA)

Make. Make Perfect. Repeat.™

Let’s discuss how we can help bring your product to market.

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