Lonza and TRACON Pharmaceuticals announced the successful delivery of the first 2,000L single-use bioreactor (SUB) batch produced from the recently expanded Lonza Singapore site. The batch was supplied under the strategic manufacturing agreement for TRACON’s therapeutic antibody TRC105.
Lonza’s 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 2,000L 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.
“As TRC105 is currently being evaluated in multiple late- and mid-stage clinical trials for the treatment of solid tumors, it is critical for TRACON to work with a trusted manufacturing partner,” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “Lonza’s technical expertise and capabilities make it the ideal group to provide commercial production of our lead product candidate, TRC105. We look forward to continuing our long-standing and beneficial relationship with Lonza.”
“The expertise in biomanufacturing at our Singapore site was a key driver for establishing additional single-use facilities there,” said Sylke Hassel, Senior Vice President for Mammalian Manufacturing, Lonza Pharma & Biotech. “We have supported TRACON since its pre-clinical phase, so to be able to produce TRC105 as our first batch in our Singapore 2,000L facility is a great motivation for our teams.”
Based on the increased demand from the market, Lonza announced the addition of multiple 2,000L 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 extensive 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.