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Drug Product Fill

We currently operate 2 drug product facilities capable of producing liquid or lyophilized bioconjugates, cytotoxic compounds and other small molecule products at varying clinical and commercial scales. For details on each DP facility, click the corresponding tabs below.

 

Filling line capabilities:

  • Filling range from 1~50mL.
  • Liquid or lyo products.
  • Isolator-based filling line technology with rapid transfer port (RTP) interface and automatic fill weight check.
  • Filling system utilizes 100% disposable materials including compounding vessel, tubing, bag, filter, and filling needle.
  • Nitrogen blanketing and light protection features.
  • Five square meter and twenty square meter lyophilizer with fully automated loading and unloading system.
  • Figure X. manufacturing capacity of XDP1.

 

Vial Size Lyo Capacity (Full Load Quantity)
5 sqm 20 sqm
2R 21,696 84,975
6R 11,316 44,957
10R 9,678 37,026
20R 6,300 23,463
50R 3,300 13,299

 

  • Fully isolated automatic aseptic filling system.
  • Vial washing machine.
  • Depyrogenation tunnel.
  • Peristaltic pump filling machine.
  • Two Lyophilizers – 5 & 20 sqm.
  • Capping machine.
  • External vial washing machine.
  • Automated parts washing machine.
  • Autoclave.

Filling line capabilities:

  • Filling range from 0.5~50mL.
  • Liquid or lyo products.
  • Isolator-based filling line technology with rapid transfer port (RTP) interface and 100% in-line weight check system.
  • Filling system utilizes 100% disposable materials including compounding vessel, tubing, bag, filter, and filling needle.
  • Nitrogen blanketing and light protection features.
  • Five square meter and twenty square meter lyophilizer with fully automated loading and unloading system.
  • High potent control design.
  • Figure X. manufacturing capacity of XDP2.

 

Vial Size Lyo Capacity (Full Load Quantity)
5 sqm 20 sqm
2R 22,736 81,950
6R 11,613 43,956
10R 10,101 37,026
20R 6,405 23,463
50R 3,542 12,980

WuXi XDC Packaging Center offers flexible layouts and both manual and automated solutions for a wide range of inspection, secondary and tertiary packaging. The state-of-the-art inspection, labeling and packaging equipment could support clients’both clinical and commercial supply locally and globally. With such facility as integral part of two DP manufacturing facilities at Wuxi new district site, we can streamline the DP inspection, labeling and packaging process, allowing quality products delivery to clients and patients safer and quicker.

 

This facility offers following service:

  • Manual, semi-auto and fully automated visual inspection of water-like, viscous and lyo drug products in vials.
  • Headspace Gas Analyzer (HGA) as leak test method for high vacuum or N2 blanket products as integrated in AIM.
  • Secondary and tertiary packaging, including labeling, cartoning, middle-box packing, end of line packing and shipment packing.
  • Drug serialization for commercial package, to meet China, European and US market requirement.
  • Size design & trial of packaging from unit carton to shipper via co-development with local suppliers.
  • Special package delivery, e.g. UV or light protective label, cap UV printing, blinded-label.
  • Supplier management of local packaging materials and artwork coordination.
  • Expedition of time to market for brand owners’ market launches.
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