Earlier this month this publication visited a number of multinational pharma firms who have made significant manufacturing investments in Ireland, including Merck & Co. (known as MSD outside North America) in Dublin and Eli Lilly who is currently constructing its second biopharmaceutical plant at its site in Kinsale, near Cork.
Amongst the topics discussed, one area of interest was the disparity of outsourcing strategy the two firms held. Lilly’s General Manager at the Kinsale site Chris Langan said though the firm “has not ruled out outsourcing as an option to be used when needed or appropriate,” the growing complexity of small molecule manufacture and a shift towards biopharmaceuticals in the make-up of its pipeline has led Lilly to focus more on in-house production.
“I fully expect to see new products in both small and large molecule pipelines,” Langan told Outsourcing-Pharma.com, adding Lilly’s pipeline currently comprises of about half small and half large molecules – a percentage expected to remain constant going forward.
“The manufacturing processes associated with both types of molecule have their own unique challenges and complexities,” he continued. “Lilly has a strategy of maintaining in-house control over more complex processes.
"We have the opportunity and responsibility to support two technology platforms in both a supply and commercialisation mission. That requires a degree of specialisation and capability that we have worked hard to build over the past several years."
As part of this commitment, the firm is scheduled to complete a €330m ($450m) 240,000 sq ft commercial scale biologics facility on site by the end of this year, with the first GMP lots set to be produced in Q1 2016.
Merck & Co.
For Merck, Vice President of Biologics & Contract Manufacturing Operations Brendan O’Callaghan told Outsourcing-Pharma.com the company has a need for greater internal capacity for its biopharma portfolio but for now uses outsourcing partners to fulfil its needs.
“There’s a lot of examples of capacity that was built in anticipation of very substantial volumes of products that didn’t necessarily materialise, so we’re leveraging that capacity as it’s available,” he told us, citing a 15-year supply partnership agreement with Medimmune leveraging a facility in Frederick, Maryland as an example.
“To bring a biologics facility on line you’re looking at a five-year time-frame, a very significant investment and so we’re choosing carefully in terms of when we would make that investment internally to fulfil our needs, and in the meantime leveraging over-capacity available externally within biopharma,” he continued.
“At the right time we will invest in internal facilities and make sure that we have that balance between internal and external at the right level. That would be our strategy more broadly across our full portfolio, not just biopharma products.”
MSD currently has two internal facilities specifically for large molecules: one in County Cork, Ireland, and the other in Oss, The Netherlands.