The plant will house five production lines with cell culture capacity of 2,000L and production capacity of 10,000L. Tot said it will use disposable bioreactor and processing systems.
The Chinese biopharmaceutical firm intends to use the facility to make antibody drug conjugates (ADC) for the local and international markets. It is scheduled to become operational in 2018 and to begin commercial production the following year.
Tot has been building up biopharmaceutical manufacturing capacity over the past few years beginning in 2012 when it opened its first production facility at the Suzhou site.
The existing facility houses an oral anti-cancer drug manufacturing area with separate production facilities for cytotoxics and non-cytotoxics, an injected anti-cancer drug plant and a GMP bio pilot plant with a capacity of 500L cell culture/ purification/ filling.
Work on the new facility follows just over six months after privately held Tot announced it had attracted what it called “new strategic shareholders.”
In March previous backer TTY Biopharm Co. had sold its Tot shareholding to a group including US investor Vivo Capital, Taiwan-based Formosa Laboratories – itself a producer of drug ingredients and ADCs – and Center Laboratories Group and Chengwei Capital.
At the time Tot said the transaction – valued at $24m (€21m) – would allow it to leverage Vivo’s experience in healthcare in both China and the US and facilitate strategic alliances including cross-border partnerships.
It also said closer financial ties with Formosa will bring benefits in bulk pharmaceutical chemical production and manufacturing.