Telephone sharing button Contact Us linkedin sharing button Share wechat sharing button Share wechat sharing button Twitter mailbox sharing button info@wuxibiologics.com
arrow_left sharing button
arrow_right sharing button

GMP Formulation, Fill and Lyophilization

The WuXi XDC ADC/bioconjugate Drug Product (DP) GMP manufacturing processes include compounding, sterile filtration, filling, lyophilization, stoppering, capping, external washing and visual inspection. The filling line contains a fully isolated, automated aseptic system which can fill liquid and lyophilized products in vial sizes of 2R to 50R.

 

  • Also available

 

    • Nitrogen blanketing
    • Light protected material handling from start of fill processing to final packaging steps
    • Liquid and lyophilization  fills for parenterals (e.g.,  small molecule and peptide therapeutics)

Vial size (mL) Filling speed
(vials/hr)
6 hrs forecasted output (Liquid) Lyophilizer (5 sqm)
Capacity (vials/batch)
Lyophilizer (20 sqm)
Capacity (vials/batch)
2 4,200 25,200 21,000 86,372
6 3,600 21,600 11,000 44,968
10 3,600 21,600 9,600 37,950
20 3,000 18,000 6,000 24,200
50 2,000 12,000 3,000 13,310

  • Key equipment

 

    • Fully-automated, isolator-based and large-scale  manufacturing fill line 
    • Washing machine
    • Dehydrogenation and sterilization tunnel
    • Filling machine
    • Lyophilizer 5 & 20 sqm
    • Capping machine
    • External washing machine
    • Rubber stopper washing machine
    • Autoclave


  • In addition to ADC/bioconjugate drug substance and drug product GMP manufacturing, WuXi XDC’s single-source bioconjugate platform includes non-GMP and GMP manufacture of all intermediates including the mAb/protein, payload and linkers.