Singapore: Clinical-Stage Pharmaceuticals Lonza Delivers First Single-Use Bioreactor Batch to Tracon Pharmaceuticals
Lonza and Tracon Pharmaceuticals announced the successful delivery of the first 2,000 L single-use bioreactor (SUB) batch produced from the supplier's recently expanded Singapore site. The batch was supplied under the strategic manufacturing agreement for the client's therapeutic antibody TRC105.
Basel/Switzerland — For the project, Lonza performed cell-line development and provided clinical supply for TRC105 at its Slough (UK) site, using the established GS Gene Expression System. The process was subsequently transferred into 2,000 L scale disposable bioreactors at the Lonza Singapore site in Tuas, which will manufacture material for Tracon’s ongoing clinical trials and, if TRC105 is approved for marketing, for global commercial supply.
TRC105 is currently being evaluated in multiple late- and mid-stage clinical trials for the treatment of solid tumors. According to Charles Theuer, M.D., Ph.D., President and CEO of Tracon, it was therefore critical to work with a trusted manufacturing partner. The expertise in biomanufacturing at the manufacturer's Singapore site was a key driver for establishing additional single-use facilities there. The company supported its customer since its pre-clinical phase.
Based on the increased demand from the market, the company announced the addition of multiple 2,000 L single-use bioreactors to its Singapore site in 2016. The additional commercial capacity has been available to customers since early 2018.
This expansion in Singapore complements Lonza’s commercial mammalian network, ranging from small-, mid- to large-scale and providing global solutions for customers at the optimal scale combined with flexibility as requirements change across the lifecycle of their product. Other operations in Singapore, including clinical development and large-scale manufacturing have continued without interruption during the set-up of the new single-use facility.