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The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.
On Nov. 5, 2018, Lonza and TRACON Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the successful delivery of the first 2000-L single-use bioreactor (SUB) batch produced from the recently expanded Lonza Singapore site as part of a strategic manufacturing agreement the two companies have for TRACON's therapeutic antibody, TRC105.
Lonza performed cell-line development and provided clinical supply for TRC105 at its Slough, United Kingdom, site using its GS Gene Expression System. The process was subsequently transferred into 2000-L scale disposable bioreactors at the Lonza Singapore site in Tuas, which will manufacture material for TRACON’s ongoing clinical trials and for global commercial supply, if TRC105 is approved for marketing.
“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, MD, PhD, president and CEO of TRACON, in a company press release. “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, in the press release. “We have supported TRACON since its pre-clinical phase, so to be able to produce TRC105 as our first batch in our Singapore 2000-L facility is a great motivation for our teams.”
Based on increased demand from the market, Lonza announced the addition of multiple 2000-L SUBs to its Singapore site in 2016, with commercial capacity made available since early 2018.
This expansion in Singapore complements Lonza’s commercial mammalian network, ranging from small-, mid- to large-scale. 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.