Symbiosis’ biologics site passes remote MHRA inspection

By Jane Byrne contact

- Last updated on GMT

© GettyImages/Elena Lukyanova
© GettyImages/Elena Lukyanova

Related tags: Biologics, Cell therapy, Gene therapy, Vaccine

Symbiosis Pharmaceutical Services reported a successful audit outcome by the UK government regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) for its Scottish production site.

Headquartered in Stirling, in the UK, the company said it recorded no critical or major observations during the reinspection, which was carried out remotely due to COVID-19 restrictions.

Symbiosis has, thus, extended its MHRA regulatory licenses for the GMP sterile manufacture of investigational medicinal products (IMPs) for clinical trials and for the manufacture of aseptically filled licensed niche commercial products. 

June saw the CMO announce a supply agreement with AstraZeneca for sterile manufacture of the COVID-19 recombinant adenovirus vaccine, AZD1222, for clinical trials.

That development came on the back of the investment Symbiosis had made at its biologics facility in Stirling, with the CMO reporting it had doubled the footprint of the plant, investing over £1.5m ($1.9m) to expand its sterile biologics manufacturing capabilities while doubling its physical footprint.

An additional space of 8,000-square-feet was added to the site, to add capacity to its manufacturing services for supply chain management and additional temperature-controlled storage, as well as automated labelling and packaging equipment.

Colin MacKay, company CEO, recently commented: “Our expertise in small-to-medium scale clinical trial and commercial sterile manufacturing continues to resonate successfully with our target client market, as demonstrated by repeated annual business growth of around 25%.

"Our recent successes in manufacturing a COVID-19 candidate vaccine further underlines the competitive strengths of Symbiosis.”

Rapid growth in cell and gene therapies fueling demand 

When MacKay spoke to BioPharma-Reporter in March​, he explained that the rapid growth of cell and gene therapies has allowed the ‘relatively smaller CMO players’, such as Symbiosis, to flourish.

“The relatively smaller CMO players, such as ourselves, are strategically working hard to increase in-house manufacturing capacity while doing so in a measured way to ensure continued compliance in line with that growth, while investing in strategic relationships with existing clients to ensure they have access to our capacity to align with the increasing manufacturing requirement of their maturing products.

“In tandem, we are adding new capacity output from our existing manufacturing infrastructure, allowing us to continue to add new, high-value, clients to our existing client portfolio who can use that growing capacity.

“Strategically, and competitively, Symbiosis is therefore well-positioned to provide sterile GMP manufacturing capacity to clients who are experiencing frustrations with the wider industry and its lack of manufacturing capacity and access to it on a short timeframe.”

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