Lonza and TRACON Pharmaceuticals, a clinical-stage biopharmaceutical company focused on novel targeted therapeutics for cancer, have successfully delivered 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 performed cell-line development and provided clinical supply for TRC105 at its Slough (UK) site, using the 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 chief executive officer 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.”