WILMINGTON, N.C.—In December, Pharmaceutical Product Development LLC (PPD) announced plans to add 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, Wis., 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. These changes in Athlone are part of our ongoing plan to ultimately mirror there the upgrades we’ve been incorporating in Middleton,” says Dr. Jon Denissen, senior vice president of the company’s bioanalytical and GMP labs.
“Coupled with the GMP lab operation in Middleton, PPD has more than 350,000 square feet of laboratory space and cutting-edge facilities and equipment to provide responsive, flexible and comprehensive CMC [chemistry, manufacturing and controls] services for small molecules, biologics and gene and cell therapy products. 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. During the 30-plus years we’ve had laboratory operations in Middleton, Wis., and eight years in Athlone, Ireland, we’ve been able to successfully grow our operations due in part to the strength of the talent in those regions and their supportive business environments,” he continues.
The GMP lab expansion will add nearly 6,000 square feet of new lab space to the existing 41,000 square feet 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. PPD Laboratories anticipates adding about 20 positions as a result of the expansion.
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.
“As the volume of biologic products has increased, the analytical testing associated with their clinical development and commercial release has become more standardized. Therefore, many pharmaceutical companies have made the strategic shift away from in-house testing and instead partner with top-tier laboratories, such as PPD Laboratories, for the analytical testing of their biologics,” Denissen comments. “By working with PPD Laboratories, pharma companies access the capacity, array of capabilities, scientific expertise, quality and regulatory compliance they need, when they need it, without the high cost associated with maintaining a large-scale, GMP-compliant biologics testing capability in-house.
“There are many commonalities between the array of analytical tests performed for various biologic products. However, there are also specific tests that are required for specific types of biologic therapies, such as replication competence and DNA sequencing for viral vector-based gene therapy products. PPD Laboratories offers the scientific expertise and capabilities to support both conventional (e.g., monoclonal antibodies) and cell- or gene-based biologics.”
PPD Laboratories’ GMP lab is a leading provider of CMC laboratory services for all phases of drug development. 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, Va.; a biomarker lab in Highland Heights, Ky,; and central labs in Shanghai, Brussels, Singapore and Highland Heights.
In November, PPD also appointed several new people to its global product development services, adding significant expertise in multiple therapeutic areas. Specifically, the company added Dr. Amy Chappell and Dr. Alberto Lledó in neuroscience, Dr. Timothy Miller in rare diseases and pediatrics and Dr. Konstantin Stoitchkov in hematology/oncology, strengthening PPD’s team of therapeutic area professionals with extensive product development and commercialization experience.
“As the drug development process continues to become more complex, our clients are looking to PPD to provide medical and scientific expertise and strategic direction that extend far beyond traditional clinical trial implementation,” concluded Dr. Rob Dow, PPD’s chief medical officer. “These experts have held senior leadership roles in various capacities in the life-sciences industry, providing them with a wide range of experience that offers significant strategic value to our clients.”
