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Scalability
MELTDOSE® HAS BEEN SCALED TO COMMERCIAL BATCH SIZES AT MANUFACTURING SITES LOCATED IN BOTH US AND EUROPE.
LCP has capability to supply GMP Clinical Trial Materials and commerical scale has been established at 3 CMOs.
| Process Step | Process Time |
| 1. Melt vehicle(s) in a pressure tank | 5 - 6 hrs |
| 2. Dissolving drug substance in melted vehicle(s) | 1 hr |
| 3. Melting drug solution sprayed on carrier particles | 1 - 2 hrs |
4. Sifting of granulate and blending of lubricant |
Done on day 2 of process |
| 5. Tabletting of product | Done on day 2 of process |
Commercial batch manufacture of 300kg accomplished in 2 days: first day for granulation and second day for tabletting.
| Scale | Type of Development |
Location/ Site |
Production Class |
| 100g - 1kg | Formulation | LCP (Denmark) | Non-GMP |
| 10kg | Formulation /CTM | LCP (Denmark) | Non-GMP /GMP |
| 100kg | CTM / Commercial | CMO (2 in EU) | GMP |
| 400kg | Commercial | CMO (US) | GMP |
MeltDose® Process Technology – Range for Development / Manufacturing Scale.
SCALABLE AND TRANSFERABLE
- MeltDose® employs conventional manufacturing equipment, does not require significant additional investment and is easily scalable to commercial batch sizes
- LCP can offer a custom-made technology transfer program to allow you to manufacture your own MeltDose® based products
- MeltDose® manufacturing process has already been established at leading CMOs in both Europe and USA