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.
“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.”
Drug development time saving
Symbiosis believes its 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 that 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”.
From the initial design, the project to add these new testing service capabilities has taken 15 months to complete, including inspection and approval from national and international regulators.
Symbiosis, which specializes in sterile fill-finish manufacture of drug products for clinical trials and commercial supplies to a global client base, can now provide a range of analytical chemistry and microbiology services as part of an expanded QC function. It also says it can now add to the process development and optimization capabilities to perfectly align with its existing core parenteral fill-finish offering.