Symbiosis has opened a new sterile manufacturing facility in Scotland for clinical trial drug supply.
The plant, in Stirling, will produce small scale injectable sterile liquids, lyophilized, cytotoxic and biological drugs for Phase I and II. It will also handle related services such as fill & finish, packaging and storage.
The company says the move – along with its recently granted MHRA (Medicines and Healthcare products Regulatory Agency) license allowing it to work with clients globally – will allow it to target the EU and US markets in particular.
Colin MacKay, founder and CEO, told Outsourcing-Pharma.com: “Our objective is to actively and aggressively drive down the amount of highly valuable drug development time.”
Small molecule drugs make up a large proportion of planned production, however Mackay told us that with a growing focus on bio drugs – for instance peptides, proteins, DNA – it will also handle biologics.
Of the type of client Symbiosis will aim its new services at, MacKay said any pharma or biopharma looking for a quick turnaround is a target.
He said the plant is “cross-recognised by the US Food and Drug Administration (FDA), combined with a unique operational infrastructure to enable Symbiosis to deliver its manufacturing services to its clients in the shortest timeframe that the industry has seen.”
Though the firm are willing to accept short-term contracts, he added, long-term relationships are the end goal. Current long-term clients include Zealand Pharma and Encap Drug Delivery.
A job well done?
In a statement, the contract manufacturing organisation (CMO) boasted a build-time of just months for the facility, “achieving a timeline never seen before in the industry”.
MacKay told us the feat was achieved because of its management team’s experience in the biotech industry, as well as a novel design initiative in which the firm asked potential clients how the facility should be shaped.
“The full detailed design of the facility was completed prior to the completion of the investment needed for the ‘build phase’ to begin which permitted fast progress to be made. Post-investment, the facility was built, qualified and MHRA licensed in under 12 months,” he said.
When asked if the unusually quick completion of the facility meant Symbiosis had cut corners, MacKay replied: “Of course we are aware of those kind of comments being made in our industry wherever the traditional approach to building a facility has been employed.
“Our approach meant we did not need to cut corners. We comprehensively designed the facility in a way which included carefully specifying materials and equipment along with agreeing realistically achievable timelines with our carefully chosen contractors in advance.”