RAPIDLY-GROWING contract manufacturing organisation (CMO) Symbiosis Pharmaceutical Services (Symbiosis), has successfully completed a scheduled inspection by the UK Government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
Headquartered in Stirling, UK, and specialising 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 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 that it had expanded its sterile biologics manufacturing capabilities significantly and invested over £1.5m ($1.9m) in its expansion, 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 successfully secured £1million of growth finance earlier this year from Allied Irish Bank (AIB)(GB) to support its ambitious 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.
“This allows us to proactively support biotech and speciality biopharmaceutical companies with products in niche markets and orphan indications that require relatively low volume or infrequent sterile filling. At the same time, it also gives us the potential to scale-up existing client projects which are successfully progressing through clinical trials and on to the market.”
Symbiosis, which also has an office in the heart of the global biotech industry in Cambridge, MA, USA, has built its reputation on supporting both pharmaceutical and biotechnology companies with its vial-filling expertise and small-scale aseptic GMP manufacturing capabilities and its ability to provide its services in a flexible way on short timelines which is highly valued by its clients.