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 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 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.