GSK will work with Lonza on the development of a UK biomanufacturing plant as part of a new MAb manufacturing contract announced today.
On the manufacturing side, Switzerland-based Lonza will make batches of five monoclonal antibody (MAb) candidates for Phase I and II trials and, assuming development progresses, provide additional capacity for later trials and subsequent commercialisation.
More significant however, from the point of view of GlaxoSmithKline’s (GSK) move into biologics, will be Lonza’s collaboration on the design and specification of a “bespoke biopharmaceutical manufacturing plant” the drug major plans to set up in the UK.
Spokeswoman Claire Brough told in-Pharmatechnologist that: "GSK selected Lonza as it one of the world's leading suppliers to the pharmaceutical industry for the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically."
Brough also confirmed that GSK will "draw upon Lonza's expertise" for the development of the manufacturing plant and added that the firm "will assess options for locating this facility in the UK during 2011."
"However," she continued "GSK will not commit to building the facility in the UK until after the proposed introduction of 'patent box' legislation by the UK government expected in 2012."
Investment in biologics
GSK, like most of its Big Pharma peers, has been cutting and reorganising in-house manufacturing and R&D capacity over the last few years in favour of outsourced production in an effort to control costs.
And, while today's sale of its research centre in Zagreb, Croatia to Belgian firm Galapagos and divestiture of its Italian R&D site to Aptuit in July indicate this process is continuing, the Lonza deal suggests that, at least in terms of biologics, GSK is prepared to invest in manufacturing capacity if the conditions are right.
In a press release accompnaying the news, Ian Tomlinson, head of GSK's biopharm research and development group, described the agreement with Lonza as “a critical step in the ongoing and future success of GSK biopharmaceuticals.”
He said that the firm wants biopharmaceutical drugs to consistently make up more than 20 per cent of its product pipeline by 2015 and explained that: “To make this a reality we need to ensure that we have the right resources in place.”
Lonza manufacturing boost
Spokesman Dominik Werner told in-Pharmatechnologist that: “Manufacture of phase I and II clinical supply takes place in GSK's own Upper Merion facilities,” after which Lonza will make stocks “for Ph III and for in-market supply for a period of time post launch.”
Werner went on to explain that, for its part of the manufacturing process, Lonza intends to use its facility in Portsmouth, New Hampshire in the US but that “this does not preclude the use of [its plant in] Singapore.”
Observers suggest that the deal, particularly the manufacturing contract, will be a boost for Lonza, which recently shifted its manufacturing focus to the production of high value, hard to make biologic drugs.
Kepler analyst Florian Gaiser for example told Reuters the new agreement is “a meaningful addition to its services and small-to-mid scale production portfolio, especially as it strengthens the relationship with key customer GSK.”