lyophilized drug product manufacturing -乐鱼全站app

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  • – aseptic filling
  • – lyophilization
  • – drug product packaging
  • – in-process control tests
  • – drug product release test
  • established pilot- and commercial-scale manufacturing workshops, equipped with grade oeb5 isolators and lyophilizers in 5m² and 20m²
  • utilizing single use filling systems, isolator integrated filling lines, and an automated loading and unloading lyophilizing system
  • capable of producing lyophilized products from 2r to 50r at up to 200 vials/min
  • the production line uses rtp (rapid transfer port) with online weighing and light-protected features. the pilot line employs 100% full weighing control, and the commercial line includes a statistical sampling weighing module with dual-scale support
  • utilizing global leading brand commercial filling line and lyophilizers, with independent designs for automated loading, unloading, and capping, enabling seamless transitions between lyophilized and liquid filling
  • boasting extensive experience with more than several dozen successful production batches
capacity of lyophilized adc
vial (ml) 2 6/8 10/15 20 50
5 ㎡ lyophilizer
22,000 11,000 9,000 6,000 3,000
20 ㎡ lyophilizer
80,000 42,000 35,000 23,000 13,000