Last month the contract manufacturing organisation (CMO) opened a plant in Stirling, Scotland , for Phase I and II injectable sterile liquids, lyophilized, cytotoxic and biological drugs. CEO Colin MacKay told Outsourcing-Pharma.com the facility was designed specifically to meet US needs.
The firm hopes the new office – in Boston – will help link its Stirling operations with the “high concentration” of biotechs in the US now moving to establishing clinical operations in the EU in the hopes of quicker approval.
MacKay told us: “Outwith North America, Europe is arguably the biggest regional market to market for pharmaceuticals. Getting regulatory approval in Europe takes time, just like in the US via the FDA process.
“There is a belief that conducting clinical trials in Europe can reduce the approval timeline in European countries. Supporting that, clinical supplies manufactured in Europe by the likes of Symbiosis, in a facility inspected and licensed by European regulators, will also facilitate that drug evaluation and approval process and potentially shorten timelines.”
The facility will also continue to provide services in Europe.
Mackay added that Symbiosis is actively seeking third party vendors in the US which “align with our client and service-orientations, and with our strategic ambitions.”
He said the company has been in talks with several firms both upstream and downstream of Symbiosis’ services, as well as with high volume competitors to try and provide a fuller, one-stop-shop experience.
“There may be scope for cross-referral of shared clients,” he explained. “However the over-arching golden rule is that the client must be the one to decide whether partnerships between service providers are is in their best interest. If so, we’ll use all of our resources to deliver on that project so that the client achieves their goals too.”
When asked if opening its own US facility in the near future is on the cards, Mackay told us it is “something we would be reckless to rule out however our short to medium-term strategic priorities are clear to us and we are focussed on delivering them.”