Symbiosis granted MHRA license following £1 million investment

The CDMO has launched the new in-house analytical and microbiological capabilities that will enable the testing.

Fully approved by the UK Regulatory Agency, the MHRA, this expansion of their service offering will strategically enhance the companies’ core sterile manufacturing service, that is 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 over £1M ($1.25M), the company has added 3,600ft² 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 sub-contracted tests. In addition, Symbiosis says it will introduce temperature and humidity-controlled stability storage capabilities in support of ICH pharmaceutical stability studies. 

New QS testing service labs

Growing demand from new and existing clients has resulted in the opening of the new QC testing service laboratories as it can provide a broader-range of in-house testing capabilities.

Symbiosis’ strategic projects director, Alison Clayton, has been leading the project.

She said: “We are delighted that Symbiosis’ analytical testing laboratories and QC function are now operational and fully approved by the MHRA. 

“This project demanded a great team effort from both Symbiosis and principal project contractors Olison Ltd. to ensure the design, build, and subsequent qualification activities were undertaken efficiently, with regulatory compliance, and with the development of an underlying quality system at the heart of the project management ethos. 

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