Antibody-Drug Conjugate (ADC), Phase II/III Development with WuXi Biologics

The Complexities of Advancing ADC Development in Oncology

A Swiss oncology biotech developing a novel antibody-drug conjugate (ADC) for a difficult-to-treat cancer. ADCs are among the most complex biologics to advance, combining the challenges of biologics manufacturing with the added complexity of linker-payload conjugation and highly potent cytotoxics.

To progress into Phase III, the biotech needed more than internal capacity. They required a dedicated CMC partner to:

• Scale up from pilot batches to hundreds of litres of GMP supply.

• Establish an end-to-end process for antibody production, conjugation, purification, and QC.

• Coordinate global quality oversight between teams in Switzerland and China.

• Prepare robust CMC modules to support IND (US), CTA (Europe), and eventual BLA submissions.

Without expert oversight, the risks included supply delays, regulatory non-compliance, and failure to meet the strict quality standards for ADC development.

Why 3Biotech as a Dedicated CMC Partner

The company selected 3Biotech for our experience in ADC development, CMC strategy, and global CDMO partnerships. We:

• Established a strategic partnership with CDMO in Shanghai, selecting them for their ADC platforms and capacity, while ensuring the biotech retained scientific oversight.

• Supervised accelerated scale-up, coordinating the transition from pilot to large-scale production.

• Integrated global quality management, creating a transcontinental project framework, conducting audits, and ensuring GMP/ICH compliance.

• Led regulatory preparation, producing complete CMC modules for IND (US) and CTA (Europe) and preparing for BLA submission.