WuXi XDC secures regulatory approval for Singapore site

The facility will join production sites in Wuxi, Shanghai, Hefei, and Suzhou.

WuXi XDC held a Good Manufacturing Practice (GMP) release ceremony for its manufacturing site at Tuas Biomedical Park on 21 September, marking its first overseas manufacturing site.

The company announced the site in March 2024 and secured GMP release for its BCM3 antibody-intermediate and conjugated drug substance production line and DP4 drug product facility in August 2026.

The site has a gross floor area of about 25,000 square metres (sq m) and will form part of WuXi XDC’s manufacturing network with sites in Wuxi, Shanghai, Hefei, and Suzhou.

The BCM3 line can handle antibody-intermediate batches of 200 litres to 2,000 litres and conjugated drug substance batches of up to 2,000 litres.

It provides manufacturing from antibody intermediates through to conjugated drug substances.

The DP4 facility has one 10-sq m and two 30-sq m lyophilisers, with annual production capacity of up to eight million vials of liquid or lyophilised bioconjugates.

WuXi XDC said its BCM4 facility is expected to receive GMP release by the end of 2026.

It will have a maximum single-batch capacity of 500 litres of conjugated drug substance.

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