Eurofins BPT Ireland has expanded and now affords global biopharmaceutical companies increased opportunities for Large Molecule and Gene Therapy Testing
Mary David, BSc, Senior Scientist Group Leader, Eurofins BPT, Dungarvan, MaryDavid@eurofinsUS.com
Large molecule therapies, biologics and especially biosimilars, are important and increasingly affordable sources of remedies around the world. Since more and more companies have been started up to develop biosimilars, there has been an equally intensified demand for testing of the safety, potency, efficacy, and identity of these therapies.
Gene therapies have exploded onto the scene, producing exciting customised treatments for specific disease states and even specific people. Customised therapies show promise and are on the rise. More and more pharmaceutical companies are racing towards clinical testing at an ever-increasing pace. Testing of gene therapeutics also for safety, potency, efficacy and identity are increasingly critical as the rapidity of development surges.
Eurofins BioPharma Product Testing Ireland, determined to meet the rising demand for testing, made significant investments in laboratory additions totalling 47,360 square feet (4,400 square meters). The Molecular Cell Biology (MCB) laboratory suites currently have multiple new Biosafety Cabinets, RT-qPCR systems, plate readers, plate washers, and much more – occupying about two-thirds of the new expansion space. And cold storage capacity is currently comprised of +5oC, -20oC, -80oC, and cryogenic storage.
As the demand for testing has increased, the last one-third, approximately 8,000 square feet, of this laboratory space expansion is being outfitted with additional new equipment and state-of-the-art instrumentation designed specifically for testing biologics and gene therapies, including ddPCR and Sanger sequencing capabilities. Continually looking ahead, new technologies, such as analytical ultracentrifugation, are also being evaluated for inclusion at the Dungarvan site.
Successfully operational for testing large molecule and gene therapeutics, the new MCB suites offer state-ofthe- art laboratories specific for cell based assays (potency, efficacy), ELISA assays (potency, identity), and qPCR assays (safety, identity). Moreover, a fully trained team of skilled scientists and team leaders continually strive to ensure that the highest level of quality is maintained and provide accurate results in a timely manner. To that, the Dungarvan site has uniquely and accurately positioned itself as a Center of Excellence.
Eurofins BPT in Dungarvan, Ireland, is proud to be proficiently testing therapeutics for multiple clients and has the capacity and expertise to launch testing for any new or established therapeutic destined for the European or worldwide marketplace. Eurofins is resolute in delivering complete GMP compliant support for every client, every time.
For more information, please visit: www.eurofinsus.com/bpt
