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GMP Drug Product Formulation, Fill and Lyophilization

The WuXi XDC ADC/bioconjugate Drug Product (DP) GMP manufacturing capabilities

As a leading Contract Research, Development and Manufacturing Organization (CRDMO), we provide a variety of Drug Product GMP manufacturing services not only for antibody drug conjugates and other bioconjugates but also cytotoxic compounds and small molecule products in WuXi XDC’s GMP manufacturing facility located in Wuxi, China. Our services include compounding, sterile filtration, filling, lyophilization, stoppering, capping, external washing, visual inspection and packaging. The filling line contains a fully isolated, automated aseptic system which can fill liquid and lyophilized products in vial sizes of 2R / 6R / 10R / 20R / and 50R. For more information on this state-of-the-art facility and our other extensive, global drug product manufacturing facilities and capacities – go here.

  • Also available

 

    • Isolator-based filling line technology with rapid transfer port (RTP) interface and automatic fill weight check.
    • Filling system utilizing 100% disposable materials including compounding vessel, tubing, bag, filter, and filling needle
    • Nitrogen blanketing
    • Light protected material handling from start of fill processing to final packaging steps
    • Five square meter and twenty square meter lyophilizer with fully automated loading and unloading system
    • Liquid and lyophilization  fills for parenterals (e.g.,  small molecule and peptide therapeutics

 

In addition, automatic visual inspection machine and automatic packaging line will be ready by end of 2022.


WuXi XDC Drug Product (DP) Manufacturing Capacity

Vial size (mL) Filling speed
(vials/hr)
6 hrs forecasted output (Liquid) Lyophilizer (5 sqm)
Capacity (vials/batch)
Lyophilizer (20 sqm)
Capacity (vials/batch)
2R 3,000 18,000

21,696

84,975
6R 3,000 18,000

11,316

44,957
10R 3,000 18,000

9,678

37,026
20R 3,000 18,000

6,300

23,463
50R 2,040 12,240

3,300

13,299

  • Key equipment

 

    • Fully-automated, isolator-based aseptic filling system 
    • Vial washing machine
    • Dehydrogenation and sterilization tunnel
    • Filling machine
    • Two lyophilizers: 5 & 20 sqm
    • Capping machine
    • External vial washing machine (post capping)
    • 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.

  • All of our manufacturing operations are overseen by our comprehensive global Quality System that has been audited by multiple regulatory agencies including the FDA, EMA, NMPA, PMDA, MFDS, HSA, ANIVSA, HPRA and Health Canada.