Successful Sterile Inspection for Scottish CMO
News Aug 20, 2015
Symbiosis Pharmaceutical Services has successfully completed a scheduled inspection from the UK Government Regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
The contract manufacturing organization (CMO) has received no critical or major observations and this comes amidst various quality-related issues affecting several other sterile manufacturing sites in the UK and US.
Symbiosis has been re-inspected and approved for the ongoing production of Investigational Medicinal Products (IMP’s) for clinical trials, In a further boost to support the growth and strategic development of the company, it received confirmation of continued authorization for the GMP-manufacture of aseptically-filled licensed commercial products following initial approval of the commercial Manufacturer ’s / Importers (MIA) license last year.
The regulatory inspection and approval of Symbiosis’ Scotland-based facility comes in the wake of several high profile pull-outs and inspection failures at sterile pharmaceutical manufacturing facilities globally.
The growing CMO continues to thrive in light of increased demand for its services and due to wider industrial trends such the number of injectable drugs in development, increased biotech funding and more oncology and orphan drugs.
Colin MacKay, CEO at Symbiosis Pharmaceutical Services, said: “Inspection failures at sterile filling sites has been a sensitive topic recently so it has been essential for us to maintain our focus on absolute GMP compliance, continual investment in meeting the latest emerging regulatory requirements and preserving our quality-driven business culture.
“Although our core business remains the sterile fill/finish of biologic and small molecule products into vials for clinical trials, the commercial license provides us with the opportunity to cater for small scale commercial manufacturing projects which the bigger CMOs see as unprofitable and therefore unattractive. Our operational flexibility and our cost base make those projects financially attractive both to us and to our clients.
“These abilities allow us to proactively support biotech and speciality pharmaceutical companies with products in niche markets and orphan indications that require relatively low volume or infrequent sterile filling. At the same time, it also gives us the potential to scale-up existing client projects which are successfully progressing through clinical trials towards market.”
Since 2011, Symbiosis has built a strong reputation for offering clients rapid access to sterile manufacturing slots and quick release of drug products to ensure tight clinical trial timelines are successfully met.
The CMO specializes in injectable medicines, which are either liquid or lyophilized formulations filled into vials. Its specialist capabilities include the ability to handle and fill antibodies, proteins, peptides, nucleic acids, cytotoxic, cytostatic and highly potent APIs including ADCs along with conventional small molecules.