Symbiosis announces successful MHRA audit and expanded facility at its Stirling, UK site
Symbiosis Pharmaceutical Services (Symbiosis), a fast-growing Contract Manufacturing Organisation (CMO) specialising in sterile manufacture of vaccines, pharmaceuticals, and biopharmaceuticals, and headquartered in Stirling, UK, announces that it has successfully completed a Medicines and Healthcare products Regulatory Agency (MHRA) inspection of its newly commissioned warehouse and storage area.
The company has been undertaking phased expansion to its manufacturing support capability, including the newly operational warehousing and storage facility at its Hillfoots Building, on the Stirling site.
As part of the commissioning of this expansion, the MHRA, the UK Government’s regulatory authority, carried out an on-site inspection as part of Symbiosis’ existing GMP licence. The inspection, completed at the end of August 2021, represents a highly successful outcome based on the inspectors’ positive feedback. The new storage and warehousing capability will be added to the existing GMP licences held by Symbiosis for the import and manufacture of clinical and commercial medicinal products.
“For the past year we have focussed on upgrading our existing world class facilities, in terms of capability and scale, in preparation for continued business growth” said Colin MacKay, CEO of Symbiosis. “This new expansion phase is the latest effort in what has been a sustained investment in both the people and the organic growth of the business over the last 10 years”.
He added: “By expanding our warehousing and storage facilities we are better placed to meet the increasingly varied demands of both established and emerging markets, such as cell and gene therapies. Our ability to handle the technical complexity of these products as well as the growth we have seen in this specialist market underpins our continued investment not only in infrastructure but in our regulatory and technical strength.
“We are proud to have successfully completed the expansion of our warehouse and storage facilities - both on time and on budget - and that the MHRA has inspected and granted us extended licence to use without any concern”.
Symbiosis has built up extensive experience with GMP clinical and commercial manufacture of Advanced Therapeutic Medicinal Products (ATMPs), vaccines, monoclonal antibodies (mAbs), antibody drug conjugates (ADCs) and small molecules.
The Symbiosis CEO concluded: “These recent developments represent the next exciting stage in the sustained growth of Symbiosis Pharmaceutical Services. As our capabilities and our physical presence continues to expand, along with our increasing headcount, we are perfectly primed to continue to grow and capitalise on our successful position in the specialist biopharmaceutical sterile manufacturing arena.”