Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

Case study: ADC Development and Manufacture In China for Global Clinical Trials

Background

In a joint ADC development program that exemplifies our in-China-for-global business model, WuXi Biologics worked closely with U.S. Ambrx Inc. and China’s Zhejiang Medicine Co. Ltd. (ZMC) to develop and manufacture a site-directed ADC for a clinical trial in an industrialized nation.  ZMC funded the project wherein Ambrx provided the technology that incorporates a non-natural amino acid into the antibody (making this ADC the first of its kind), and WuXi Biologics provided full CMC support from cell-line optimization to ADC conjugation to fill/finish and release.

Challenge

  • Low antibody production yield due to pre-mature truncation
  • Difficulty in toxin synthesis (many chiral centres)

Solution/Results

  • Improved protein production process by optimizing cell culture media
  • Designed appropriate synthetic route for toxin and developed efficient purification methods
  • Implemented effective project management and communication mechanism among three companies and various WuXi AppTec service units.
  • Three batches of ADC (100g each), one for toxicology studies and two for clinical trials, were manufactured and delivered meeting all specifications/release requirements.
  • The project took only 18 months to finish.

Learn more about antibody drug conjugates technology and manufacturing on The Cell Culture Dish.

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