Fully approved by the UK Regulatory Agency the MHRA, this expansion of their service offering will strategically enhance the companies’ core sterile manufacturing service (also referred to as “fill/finish”) and provide an extensive in-house quality control (QC) function to support the products aseptically manufactured by Symbiosis.
With a total investment of more than £1m [$1.25m], the company has added 3600 sqft of new space, significantly expanding its existing GMP operational footprint on the Stirling Innovation Park in Scotland.
The new laboratories will offer dedicated in-house microbiology and analytical testing capabilities, and sterility testing, to supplement the existing broad range of subcontracted tests.
In addition, Symbiosis will introduce temperature and humidity controlled stability storage capabilities in support of ICH pharmaceutical stability studies.
The opening of the new QC testing services laboratories is in response to growing demand from new and existing clients for the provision of a broader range of in-house testing capabilities.
The project was led by Symbiosis’ Strategic Projects Director, Alison Clayton, who said: “We are delighted that Symbiosis’ analytical testing laboratories and QC function are now operational and fully approved by the MHRA."
“Our colleagues and partners have worked hard to establish a fantastic analytical testing capability, which will now allow Symbiosis to meet the growing needs of its clients and will support the continuation of the impressive growth trajectory of the company.”
Symbiosis’ improved drug testing and analytical capabilities will enable greater control over the scheduling of tests while accelerating the generation of test results, meaning an overall drug development time saving for clients, reduced regulatory risk and accelerated timelines for therapies reaching patients.
CEO Colin MacKay added: “The new laboratories that we have built will further propel the continued strategic growth of Symbiosis by adding value to the drug development projects which our clients entrust to us."
"We are proud to combine an existing world class quality system with brand new analytical service laboratories which will serve to shorten our clients' drug development timelines and bring them value by getting their medicines to patients more quickly."