PPD adds cell-based assay services in Ireland to service EU demand

22-Jan-2015 - Last updated on 23-Jan-2015 at 08:08 GMT

PPD expands GMP lab in Athlone, Ireland

PPD is expanding its GMP services in Ireland to support regulatory requirements for the growing number of biopharmaceutical drugs in development.

A laboratory for cell-based assays housing approximately 20 bioassay scientists will be added to the CRO’s current operations in Athlone, Ireland, servicing firms developing biopharmaceuticals for the EU market.

“The increased number of biopharmaceuticals and need from a regulatory perspective to have a cell-based assay as part of the analytical criteria, make the addition of cell-based assays, and ability to support such testing, important factors,” PPD’s executive vice president of global laboratory services David Johnston told Outsourcing-Pharma.com.

Cell-based assays are used to establish the potency and stability of a biopharmaceutical product in order to establish safety and efficacy profiles and this is “a critical component of analytical programmes supporting the development and release of certain biopharmaceuticals,” he added.

The validation of bioassays for product release and the stability testing of biologics are services already offered at PPD’s Middleton, Wisconsin, GMP lab which was subject to its own expansion last year.

The Ireland expansion will support new programmes for clients and studies in Europe and will also “be critical for global clients working with PPD who want to develop and release into the EU market place,” Johnson added, though no work currently undertaken at the Wisconsin site will be transferred to Athlone.

The clinical testing site, located about 100km West of Dublin, was opened in 2010 due to demand from existing customers that had used PPD’s GMP cell lab services in the US. “We have continued to add new positions and capabilities as we’ve grown the location to support our European clients,” Johnson said.

“It made perfect sense to expand in Athlone at our existing GMP facility to support cell testing capabilities. The existing facility is compliant with cGMP regulations, and we have access to an excellent and highly trained skill set, due in part to our partnership with NIBRT [Ireland’s Government funded biomanufacturing institute which trains workers in the life science sector in upstream and downstream bioprocesses, as well as bioanalysis].”