CPhI Online

- Certification

Successful MHRA regulatory inspection for Scottish CMO Symbiosis

29 Sep 2020

Inspection conducted remotely using video-conferencing and an online private document sharing platform.

Symbiosis Pharmaceutical Services, a rapidly growing contract manufacturing organisation (CDM), 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.

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 more than £1.5 million ($1.9 million) in its expansion, doubling its physical footprint.

In June this year, Symbiosis announced a supply agreement with AstraZeneca for the manufacture of its COVID-19 candidate vaccine. It also successfully secured £1 million of growth finance earlier this year to support its ambitious 2020 growth strategy.

Colin MacKay, CEO at Symbiosis, said: “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."

Read More

Related Content