XBiotech’s Director of Quality Control, Qian Wu, Ph.D., will give a presentation on the Company’s high throughput bio-analytical assay development and validation to support manufacturing and product release at the Americas Antibody Congress 2015, being held May 27-28, 2015 in San Diego, CA. Dr. Wu’s presentation, titled “High Throughput Bioanalytical Assays to Support Phase 2/3 Monoclonal Antibody Manufacturing and Drug Product Release and Stability,” will be presented on May 28 during the Downstream Processing World Conference.
XBiotech’s Quality Group has been able to develop high-throughput and reliable bio-analytical methods to support manufacturing process in real-time, and also to assess product quality and stability to ensure safety and efficacy. With the ongoing pivotal Phase 3 clinical trials both in Europe and US, and expected scale up of manufacturing production, XBiotech quality group is utilizing its proprietary technology to provide the best real-time support to ensure product release and quality.
Dr. Wu commented, "As a leader of developing high throughput bio-analytical methods, we are very glad to present our data of assay development and validation to those in the antibody industry. Assay turnaround time and performance could possibly be hurdles to release product to the clinics, and we believe we have an excellent group of scientists and technicians who ensure product safety and efficacy as well as timely release of drug products to benefit patients."