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Human Genome Sciences (HGS, Rockville, MD) has selected Lonza (Basel, Switzerland) as its contract manufacturer for the future commercial supply of Benlysta.
Human Genome Sciences (HGS, Rockville, MD) has selected Lonza (Basel, Switzerland) as its contract manufacturer for the future commercial supply of Benlysta. Benlysta is a monoclonal antibody (MAb) co-developed by HGS and GlaxoSmithKline (London, UK) for systemic lupus, and is currently under review in the US and Europe.
If the drug is approved, HGS will have enough in-house manufacturing capacity for the first year or two of commercial production, says Curran Simpson, senior vice president of operations at HGS.
Industry analysts calculate the potential patient population for Benlysta around 120,000 patients, who would consume a total of about 1,000 kg of drug per year at the proposed commercial dose of 10 mg/kg.
"In addition to extending our capacity, working with Lonza also will mitigate supply chain risk," Simpson said. "That is particularly important with a drug for an unmet medical need."
Technical transfer to Lonza should be straightforward, because Benlysta is made using a standard MAb manufacturing process. Furthermore, the scale-up work is already done, because HGS scaled up early and manufactured much of its Phase 3 material at commercial scale, in 20,000-L bioreactors.
"We selected Lonza as they offer a strong track record for providing commercial supply of biologics, and have a facility which has similar design and equipment to our LSM [large-scale manufacturing] facility," Simpson added. "From a capacity standpoint, they are ideally suited to meet our long term potential requirements."
Production will take place at Lonza's site in Portsmouth, NH. If additional capacity is required for Benlysta beyond Portsmouth, HGS also will have access to Lonza's manufacturing facility in Singapore.
July 7, 2010
Bold Manufacturing Strategy Soon to Pay Off for Human Genome Sciences