The firm recently opened its £6m ($10m) Newburn facility near Newcastle, UK, and - in what it calls a “bold move” for a contract manufacturing organisation (CMO) - has dedicated empty cleanroom space to allow clients to design their own projects.
SCM’s Managing Director, Dianne Sharp told Outsourcing-Pharma.com “50% of the current developed space is available for this concept at the Newburn facility, along with a further four cleanrooms at our existing Clinical Trial HQ in Prudhoe.”
The service contrasts the usual CMO approach of using fixed-equipment capabilities, but Sharp told us that both facilities were constructed on this basis, with “flexible spaces so that processes can be developed to fit products, not the other way around.”
Such facilities are a response to the needs of clients, she continued, as drug development’s evolution has led to the latest drugs “often smaller volume, potent, injectibles, or device/drug combinations.”
“Clients need a 'blank canvas' approach to develop processes that best suit their drugs, the volumes and its complexities, and facilities to match.”
One area Sharp said demonstrated the changing demand in the industry was in potent products, such as cytotoxics, which a recent Frost & Sullivan report high-lighted as a key growth area for CMOs in the next few years.
Disposable Systems
As for the logistics and cleanliness of malleable operational areas, Sharp explained: “It is 'empty' but very clean space!
“Rooms are booked for campaign slots with equipment designed to wheel in and wheel out of the rooms and stored on site in our engineering area when not in use.”
Furthermore, she continued: “We are using more and more disposable isolator technology systems as well which allow basic frameworks to be re-used but have product dedicated isolator bags.”
Newburn received regulatory approval in June from the UK’s MHRA and SCM told this publication at the time it had earmarked operations to commence for its first client at the back end of summer.
Sharp said this was still the case “and the product is in the last stages of transfer from the Prudhoe facility to its dedicated line in the Newburn facility.” However, she could not reveal who the client was though it is a customer SCM has worked with for a number of years.