Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

Designed and constructed based on U.S., EU and Chinese cGMP requirements and through the review and assistance of several large pharma partners, WuXi Biologics clinical-scale bulk drug substance manufacturing facilities and production suites are available to serve projects on a campaign basis. We currently have three production suites on our Wuxi city campus and each suite comprises separate cell expansion, cell culture and purification areas (including separate pre- and post-viral downstream processing areas). For cell culture we only utilize disposable bioreactors. We are capable of implementing single-use/disposable technologies throughout the entire upstream and downstream process based on clients’ requirements.

Mammalian Cell Culture Capacity

  • Fed-batch: 50 L, 200 L, 500 L, 1,000 L & 2,000 L
  • Perfusion: 200 L (ATF6™), 2 x 1000L (ATF10™)
  • Concentrated Fed-batch manufacture is also available

Validated in-house utilities

  • Dedicated HVAC systems
  • GMP warehouse
  • Two independent power lines
  • Back-up diesel generator
  • UPS for critical equipment and instrument
  • Biowaste and waste water treatment

Project Management

A dedicated project manager oversees all aspects of a sponsored project. Together with a project/client specific CMC leader, the PM serves as a point of contact to streamline communication and interface with project team members to ensure deliverables and cost objectives are met on time. To facilitate sponsor interaction throughout the project, we always welcome sponsors to work on-site during technical transfer, to assist in critical project phases, or as a “person-in-plant.”

Achievements/Milestones:

  • 1st batch of DS and DP produced in China at 2000 L bioreactor scale of a monoclonal antibody therapeutic used for U.S. clinical trial in Q2 2014
  • 2014 ISPE “Facility of the Year” Honorable Mention award
  • 1st batch of DS and DP produced in China of a fusion protein that received EMA QP declaration for Phase IIB clinical trial in Q3 2015
  • 1st batch of DP used in Australia for a clinical trial Q1 2015
  • 1st batch of DS and DP expected to be used for clinical trials in Singapore Q4 2015
  • 1st manufacture of PPQ lots in China completed to support U.S. BLA filing (PAI expected Q3 2016)
  • 1st innovative ADC manufacturing/development partnership in China
Case study:

Growing NS0 cells in disposable bioreactors and scale-up to 2,000 L

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