PPD has expanded its GMP analytical lab in Middleton, WI. The new 32,000-sq.-ft. lab supplements the company’s existing biologics capacity and was constructed specifically for the stability and quality control testing of large molecule drug products. 

It has space for more than 100 new employees, and was designed to be efficient, containing specialized areas dedicated to particular types of assays and scientific instrumentation unique to biologics. The facility has met GMP regulatory requirements, has been released for use and is already supporting new client projects. 

“The expansion of our biologics testing, which nearly doubles our analytical testing capacity, enables us to meet the ever-growing needs of our clients for GMP testing of large molecule products,” said Jon Denissen, Ph.D., senior vice president of the PPD Laboratories bioanalytical and GMP labs. “From early clinical development through commercial release testing, clients rely on our industry-leading capabilities in large molecule product testing. With deep expertise that spans the full spectrum of protein-based and gene-based biologics, we support many of the most cutting-edge immuno-oncology, gene therapy and cell therapy agents being developed or marketed today. PPD Laboratories is the laboratory of choice for companies seeking high-quality data for biologics regulatory submission and product release.”

The Middleton campus expansion also includes the renovation of PPD’s existing cell lab, which will double the capacity for GMP cell-based assays. The expanded 5,900-sq.-ft. lab will support a total of 70 cellular and molecular biology scientists upon icompletion in mid-2018.