PPD Expands GMP Biologics Testing Capacity

Pharmaceutical Product Development, LLC (PPD) has expanded its GMP (good manufacturing practices) analytical laboratory in Middleton, Wisconsin. PPD Laboratories’ new 32,000-square-foot GMP analytical laboratory supplements the company’s existing biologics capacity and was constructed specifically for the stability and quality control testing of large molecule drug products.

With space for more than 100 new employees, the lab was designed with efficiency in mind, 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-square-foot laboratory will support a total of 70 cellular and molecular biology scientists upon its completion in mid-2018.

PPD Laboratories’ GMP lab is a leading provider of chemistry, manufacturing and controls (CMC) laboratory services for all phases of drug development.

The Middleton GMP lab offers fully integrated solutions for pharmaceutical product development, including analytical testing services, method development and validation, stability testing, quality control and release testing. In addition to biologic testing, the laboratory is a market leader in the analysis of small molecule and inhalation products, as well as extractables and leachables testing.

In addition to the GMP lab in Middleton, PPD Laboratories has a GMP lab in Athlone, Ireland, to meet the CMC testing needs of the European market. PPD Laboratories’ operations also include: a bioanalytical lab in Middleton; vaccine sciences, bioanalytical and biomarker labs in Richmond, Virginia; central labs in Shanghai, China; Brussels, Belgium; Highland Heights, Kentucky; and Singapore; and a biomarker lab in Highland Heights.