GMP Formulation, Fill and Lyophilization

The WuXi XDC ADC/bioconjugate Drug Product (DP) GMP manufacturing processes

The WuXi XDC ADC/bioconjugate Drug Product (DP) GMP manufacturing processes include compounding, sterile filtration, filling, lyophilization, stoppering, capping, external washing and visual inspection. The filling line contains a fully isolated, automated aseptic system which can fill liquid and lyophilized products in vial sizes of 2R to 50R.

Also available

- Nitrogen blanketing
- Light protected material handling from start of fill processing to final packaging steps
- Liquid and lyophilization fills for parenterals (e.g., small molecule and peptide therapeutics)

Vial size (mL)	Filling speed (vials/hr)	6 hrs forecasted output (Liquid)	Lyophilizer (5 sqm) Capacity (vials/batch)	Lyophilizer (20 sqm) Capacity (vials/batch)
2	4,200	25,200	21,000	86,372
6	3,600	21,600	11,000	44,968
10	3,600	21,600	9,600	37,950
20	3,000	18,000	6,000	24,200
50	2,000	12,000	3,000	13,310

Key equipment

- Fully-automated, isolator-based and large-scale manufacturing fill line
- Washing machine
- Dehydrogenation and sterilization tunnel
- Filling machine
- Lyophilizer 5 & 20 sqm
- Capping machine
- External washing machine
- Rubber stopper washing machine
- Autoclave

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.