Symbiosis Pharmaceutical Services has successfully completed a scheduled inspection by the UK Government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
Headquartered in Stirling, UK, and specializing in the sterile manufacture of vaccines, pharmaceuticals and biopharmaceuticals for clinical and commercial use, Symbiosis recorded no critical or major observations from the reinspection by the MHRA.
In order to comply with the prevailing UK COVID-19 pandemic response guidelines, the inspection was conducted by remote inspection over a number of weeks using video-conferencing and an online private document sharing platform.
As a result of this successful audit outcome, Symbiosis has extended its MHRA regulatory licenses for the GMP sterile manufacture of Investigational Medicinal Products (IMPs) for clinical trials and the manufacture of aseptically-filled licensed niche commercial products.
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The regulatory inspection and approval of Symbiosis’ Scottish facility comes after the company announced earlier this year that it had expanded its sterile biologics manufacturing capabilities significantly and invested over £1.5m ($1.9m) in its expansion, doubling its physical footprint.
“The whole Symbiosis team is pleased with the successful outcome of this regulatory inspection, performed remotely in line with COVID-19 pandemic response guidelines,” Colin MacKay, CEO at Symbiosis said. “Quality is a fundamental part of our business ethos and this reinspection success is a positive reflection of the caliber 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 successfully secured £1million of growth finance earlier this year from Allied Irish Bank (AIB)(GB) to support its 2020 growth strategy.