WILMINGTON, N.C.--Pharmaceutical Product Development, LLC (PPD) is expanding its cGMP cell-based assay laboratory in Middleton, Wis., to meet the growing needs of clients seeking to validate bioassays for product release and stability testing of biological products, both as novel drugs and as biosimilars. The Middleton cell lab will now support a significantly greater volume of bioassay development, validation and testing projects and provide a broader range of product testing capabilities.
"Biotech and pharmaceutical companies are shifting their strategies to developing high-value, niche therapies utilizing biologics, a trend that is expected to generate significant growth in characterization of biologics, as well as biosimilars," said Magdalena Mejillano, Ph.D., vice president of cGMP labs for PPD. "Expanding our capabilities to perform additional cell-based assays that establish the potency and stability of these biologics gives clients greater capacity, flexibility and efficiency in testing their products."
PPD's cell-based lab initially was created to address and respond to requirements for development, validation and testing under established U.S. Pharmacopeial Convention, International Conference on Harmonisation and U.S. Food and Drug Administration cGMP guidelines. The cell lab facility has been expanded to approximately 6,800 square feet, which will allow for a much broader range and increased volume of testing capabilities. The expansion will add the following capabilities: ability to handle ISO-certified clean-room growth and qualification of cell lines; quarantined segregation of early development projects; increased bioassay capacity and segregation of projects; and BL2/3 isolation for working with viral-based products.
PPD is a leading global provider of CMC testing across all phases of drug development with services ranging from early characterization and formulation and method development through commercial release and stability testing. Services are performed in Athlone, Ireland; Wayne, Pa.; and Middleton. The company's industry-leading facilities are equipped with state-of-the-art laboratory instrumentation to carry out a vast array of analytical methods that have been developed for small and large molecules.
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 12,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about the expansion of PPD's cGMP cell-based assay laboratory, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: rapid technological advances that make our services less competitive; competition in the outsourcing industry; compliance with drug development regulations; PPD's ability to win new business; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; loss, delay or modification of large contracts; higher-than-expected cancellation rates; consolidation in the pharmaceutical and biotechnology industries; risks associated with and dependence on strategic relationships; the rate of conversion of backlog into revenue; actual operating performance; the ability to control SG&A spending; risks associated with acquisitions and investments; the ability to attract, integrate and retain key personnel; and changes in the regulation of the drug development process. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD's estimates or views as of any date subsequent to the date hereof.