In order to comply with the prevailing UK COVID-19 pandemic response guidelines, the inspection was done by remote inspection over a number of weeks
Symbiosis Pharmaceutical Services (Symbiosis), has completed a scheduled inspection by the UK Government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
The company recorded no critical or major observations from the reinspection by the MHRA.
As a result of the audit outcome, Symbiosis has extended its MHRA regulatory licences for the GMP sterile manufacture of Investigational Medicinal Products (IMPs) for clinical trials and the manufacture of aseptically-filled licensed niche commercial products.
The regulatory inspection and approval of Symbiosis’ Scottish facility comes after the company announced earlier this year a $1.9m expansion to its its sterile biologics manufacturing capabilities, doubling its physical footprint.
Colin MacKay, CEO at Symbiosis said: “The whole Symbiosis team is pleased with the successful outcome of this regulatory inspection, performed remotely in line with COVID-19 pandemic response guidelines.”
“Quality is a fundamental part of our business ethos and this reinspection success is a positive reflection of the calibre and investment in our quality system and the recruitment of highly skilled and experienced colleagues to ensure that we remain a market leader and provide the highest quality and compliance standards to our clients.”
In June this year Symbiosis announced a supply agreement with AstraZeneca for the manufacture of its COVID-19 candidate vaccine. It also secured £1million of growth finance earlier this year from Allied Irish Bank to support its 2020 growth strategy.
MacKay added: “The company continues to thrive as a high-performing CMO fuelled by sustained increases in demand for its services and backed by broader industry trends such as the number of injectable drugs in the industry’s collective drug development pipeline.
“Maintaining our high standards of both customer service and quality compliance is part of a long-term strategy to drive the continued organic growth of our core sterile manufacturing service offering principally to the US and European markets."