PPD this week announced a new analytical laboratory at its existing facility in Middleton, Wisconsin. The lab will expand PPD’s testing capacity, according to an announcement Wednesday by the Wilmington-based company.
The 32,000-square-foot Good Manufacturing Practices (GMP) lab “supplements the company’s existing biologics capacity and was constructed specifically for the stability and quality control testing of large molecule drug products,” the news release stated.
Planned for a workforce of more than 100, the new lab contains specialized areas designed for particular types of assays and scientific instrumentation specific to biologics, according to the release.
Biological products, or biologics, include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins.
According to the Federal Drug Administration, biologics – as distinguished from chemical synthetics – are products isolated from a variety of natural sources.
“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,” Jon Denissen, senior vice president of the PPD Laboratories bioanalytical and GMP labs, said in the release. “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 is also renovating its existing cell lab at the Middleton campus to double the lab’s capacity for GMP cell-based assays, the release stated, adding, “The expanded 5,900-square-foot laboratory will support a total of 70 cellular and molecular biology scientists upon its completion in mid-2018.”