GMP Conjugation Manufacturing

The conjugation manufacturing process for ADC/bioconjugate drug substance

At WuXi XDC, the conjugation manufacturing process for ADC/bioconjugate drug substance starts with payload-linker dispensing and consists of the conjugation reaction, purification and bulk filling.

There are two dispensing cabinets for weighing and dissolving highly-potent compounds, which include a stainless steel negative pressure isolator and a single-use plastic isolator.

See the table below for manufacturing capacities.

	mAb	Payload-Linker	ADC
Lab scale	√	√	√
Non-GMP pilot scale	√	√	√
cGMP manufacturing	> 2 kg	> 5 kg	Up to 5 kg

Key equipment

- OEB5 Isolator for payload-linker dispensing and dissolution
- Mixing tanks (10 L, 50 L, 100 L, 200 L, 500 L, and 1,000 L)
- Single-use glass or plastic bioreactors , (5 L, 15 L, 30 L, 50 L, 100 L, 200 L and 500 L)
- AKTA Ready, UF/DF system

Bioconjugation is conducted at our Drug Product manufacturing facility (DP3) located in Wuxi, China. For more information on the site’s capabilities and capacities – click here

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.

For more information

White paper: The Watershed Moment for ADCs has Arrived

Podcast: Antibody Drug Conjugate (ADC) Development And Manufacturing Challenges And Solutions

Webinar: Antibody Drug Conjugates (ADC) drug development and manufacturing trends, challenges and solutions