The addition to Celerion’s Belfast, Northern Ireland facility comprises a negative pressure processing room which houses a Biosafety Level (BSL-2) cabinet and will enable the company to process live class 2 and 3 biological products.
The expansion was, according to Celerion Vice President of Global Clinical Research Phil Bach, “driven by the needs of clients and market demands.”
Speaking with Outsourcing-Pharma.com, he continued to say the containment room would “complement” the company’s offerings to biologic developers.
“By enhancing our ability to handle biological drug products in our clinics, clients can benefit from a more complete service that includes clinical study conduct, relevant bioanalysis and data analysis.”
According to the US Centres for Diseases Control and Prevention, there are three classes for biosafety containment rooms. Class 2 - which Celerion has added - is fairly common amongst clinical research companies working with indigenous or exotic agents which may cause serious or potentially lethal disease after inhalation, including various bacteria, parasites and viruses.
There has been a shift recently towards early biologic developments in the industry and it has been reported that early stage contract research organisations (CROs) have been forced to follow suit. Covance recently spoke of how outsourced preclinical work has generally dried up as biologics require less preclinical work than traditional small molecules.
For Celerion, the biologic product services aim, according to Bach, “to expand access to relevant patient populations for early drug development of biologics and biosimilar drugs.”
“Our focus is to generate “fast-to-patient” strategies that minimize the time for our clients to reach key go/no-go decisions. Celerion’s close relationship with our clients alerts us to emerging needs in the market place.”
In January Celerion added a dedicated Bronchoscopy Suite to its Belfast site increasing its ability to explore the expression and quantification of protein biomarkers within the fluid lining of the lower respiratory tract.