Symbiosis has received US FDA approval for viral vector manufacturing fill/finish at its biomanufacturing facility in Stirling, UK. In this Q&A, CEO Colin MacKay explains the significance of the accreditation with regards to industry demand and Brexit.

Scottish contract development and manufacturing organization (CDMO) Symbiosis Pharmaceutical Services constructed its sterile manufacturing facility in 2011 and has had UK regulatory accreditation since 2012.

The firm recently received approval from the US Food and Drug Administration (FDA), something CEO Colin MacKay told BioProcess Insider about ahead of the CPhI Worldwide event where Symbiosis was exhibiting.

Symbiosis’ aseptic viral vector facility is located in Stirling, Scotland. Image: iStock/Bas Kluijtmans

BPI: What does the FDA accreditation mean for Symbiosis?

CM: “The successful completion of our first FDA inspection earlier this year positions Symbiosis perfectly to support the global market, including US biopharma clients developing viral vector products for commercial markets in particular.

“We are now approved to manufacture commercial products for both the US and European markets.  Equally, Symbiosis is already supporting both European and US clients in developing their viral vector products however the successful FDA inspection further enhances our credibility, and further strengths our wider competitive position in the US market specifically.”

BPI: The UK is set to leave the European Union (EU) and the common market in March 2019. There is a fear trade deals between the UK and Europe will be ruptured. Does having US approval give you some extra security ahead of Brexit?

CM: “[The inspection] positions Symbiosis very well with regards to the opportunities for clinical and small-scale commercial manufacturing in the United States, where we already generate over 30% of our revenues.

“Regardless of any potential impact of Brexit – which remains unknown – Symbiosis will continue to proactively develop its business in the US. If Brexit has the net impact of enhancing the competitive position of Symbiosis in the eyes of US-located potential clients, we are well primed to service that demand as part of our continued efforts to develop long-term relationships with biotechnology and pharmaceutical drug development organizations in the US.

Colin MacKay, CEO, Symbiosis

BPI: Are you worried about some of your current contracts with EU customers? 

CM: “The lack of clarity regarding the details of Brexit, and therefore what it will actually mean in practice, is no doubt a worry to the pharmaceutical industry as a whole – to some extent or another.

“From the Symbiosis perspective, our EU customers have chosen to engage Symbiosis because of our particular competitive strengths, and those attributes will remain post-Brexit. There is, for example, potential short-term customs and importation challenges which may act to slow down the movement of goods which is concerning the wider pharmaceutical industry, and most other industries too. In socio-political and healthcare terms, the criticality of retaining the necessary supply of pharmaceuticals to patients both inside and outside of the UK invites a level of confidence that the potential impact of Brexit on our EU customers would be minimized at a Government level given the imperative to ensure that patient needs come first.

“Symbiosis continues to prepare for Brexit and to work jointly with its EU clients to make plans – to the best of our ability – to mitigate the business and patient supply risks from Brexit, and we carefully monitor the ongoing UK/EU negotiations for signs of strategic clarity.”

BPI: Earlier this year, you and fellow CDMO Cobra Biologics received a collaborative £1.9million (US$2.4 million) grant from the UK governments’ funding body, Innovate UK. How did this directly support the FDA’s visit and approval? 

CM: “The grant allows Symbiosis and our Innovate UK grant collaboration with Cobra Biologics to build both a better business and a better technical interface between our organizations, which facilitates the smoother transition of viral vector manufacturing projects between CMOs and expedites their route to market. In such a rapidly developing biopharmaceutical field, and with clinical timeframes shortening with the support from the regulators, clearly ‘time is of the essence’ to all of our clients, and to the oncology patients who receive these life-transforming immuno-oncology treatments.

“Both the successful FDA inspection earlier this year and the successful award of the Innovate UK grant project each represent milestones which have served to significantly bolster the ability of Symbiosis to service the market for both clinical and commercial supply of sterile GMP viral vector drug products, and have done so in a way which is complementary to each other and to the prevailing business growth strategy.”

BPI: Finally, are there plans to expand viral vector manufacturing further, or indeed branch out into other biomanufacturing functions? 

CM: “The current strategic focus of Symbiosis is on the organic growth of our core services in our target markets. Expanding the level of viral vector sterile manufacturing is very much part of our current strategy, and we have a number of on-going specific initiatives which are supporting that expansion.

“Our principal expertise is in the sterile manufacture of injectable biological and conventional pharmaceuticals for clinical trials and niche commercial markets. We are not a biomanufacturer in terms of synthesizing biological drug substances and have no strategic ambition to enter that field.

“We respect that true biomanufacturing requires a different kind of expertise, which we can help our clients to source through the existing relationships we have with partners.  We remain strategically focused on being the most flexible, time-focused and compliant sterile manufacturer in our marketplace.”