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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 StepProcess Time
1. Melt vehicle(s) in a pressure tank5 - 6 hrs
2. Dissolving drug substance in melted vehicle(s)1 hr
3. Melting drug solution sprayed on carrier particles1 - 2 hrs

4. Sifting of granulate and blending of lubricant

Done on day 2 of process
5. Tabletting of productDone 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

100 - 500gFormulationLCP (Denmark)Non-GMP
1kgFormulationLCP (Denmark)Non-GMP
5kgFormulation / CTMLCP (Denmark)Non-GMP / GMP
30kgCTMLCP (Denmark)GMP
100kgCTM / CommercialCMO (2 in EU)GMP
300kgCommercialCMO (US)GMP

MeltDose® Process Technology – Range for Development / Manufacturing Scale.

Oral Bioavailability

Improve Solubility

Scalable and Transferrable

  • 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