PPD Expands GMP Lab Testing Capabilities for Biologics

Pharmaceutical Product Development, LLC (PPD) is adding gene and cell therapy analytical testing to its GMP (good manufacturing practices) laboratory in Athlone, Ireland, to support the pharmaceutical industry’s growing need for biologics testing. The enhancements in PPD® Laboratories’ Athlone location complement the ongoing capacity and capability expansions at its flagship GMP lab in Middleton, Wisconsin, enabling the company to expand the global reach of its industry-leading biologics testing services.

“PPD Laboratories has been focused on providing cutting-edge gene and cell therapy analytical testing services and capabilities around the world,” said Jon Denissen, Ph.D., senior vice president of the company’s bioanalytical and GMP labs. “These changes in Athlone are part of our ongoing plan to ultimately mirror there the upgrades we’ve been incorporating in Middleton. Our goal is to offer the same extensive biologic, gene and cell therapy portfolio to clients in both Europe and North America, giving them additional opportunity to bring their valued assets to our scientific professionals at either GMP location.”

The GMP lab expansion will add nearly 6,000 square feet (540 square meters) of new lab space to the existing 41,000 square feet (3,850 square meters) at the Athlone facility. The new space will be primarily devoted to biologics testing and will enable the company to add quantitative polymerase chain reaction (qPCR) platforms for contaminant testing for biologics, which is a new capability for the Athlone location. The company anticipates adding about 20 positions as a result of the expansion.

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

The Athlone GMP lab offers fully integrated solutions for pharmaceutical product development, including analytical testing services, 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 labs in Athlone and Middleton, 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.