To accommodate the rapid growth of the pharmaceutical and medical device industries in Ireland, Charles River’s Biologics group will be adding to its current capabilities in Ballina. The additional assays will include in vitro adventitious agent (AVA) and mycoplasma testing along with an analytical portfolio of assays for release testing, short- and long-term stability, and comparability testing for biosimilars.
The new in vitro AVA capabilities will complement the in vivo methods for the detection of viral agents already in place (i.e., in vivo biosafety and mouse, hamster, and rat antibody production assays) in Ballina. Having both in vitro and in vivo capabilities at this site will allow us to offer the complete package of viral safety testing at a single location. The mycoplasma testing being established in Ballina will include both the indicator cell culture method and culture methods using agar plates and liquid media. The establishment of the AVA and mycoplasma methods in Ballina will supplement the capacity for this testing already offered at our Germany and Scotland sites.
In addition to mycoplasma and viral testing, Ballina will also leverage the current analytical capabilities in place in Edinburgh, Scotland and transfer many of these methods to Ireland. These methods can be used for general protein characterization purposes and also to establish lot release and short- and long-term stability programs.
These methods include:
|Physicochemical Characterization and Identity Confirmation/Comparability|
|Concentration/Strength/Recovery/Solubility||Total protein assays|
|Drug Product Properties (Liquid and Lyophilized forms)||Appearance|
Currently, we are in the process of finalizing the installation, qualification, and validation of the newly purchased equipment for the additional assays and will commence the transfer and qualification of the test methods at the beginning of 2018. We expect the new laboratories to be operational and the methods established by the end of Q2 2018.
If you are interested in learning more about these assays or to inquire on placing your testing programs in Ireland or our other sites, please contact us at [email protected].