Pharmaceutical Product Development, LLC is to expand its current GMP cell-based assay laboratory

To address the growing needs of the organization’s cliental, Pharmaceutical Product Development’s cell-based assay laboratory is to be extended to enhance its service capabilities.

Global CRO, Pharmaceutical Product Development (PPD), LLC, based in Wilmington (NC, USA), has announced the expansion of its current GMP cell-based assay laboratory, which is headquartered in Middleton (WI, USA), to meet the increasing demands of clients seeking validation of bioassays for product release and the stability testing of biological products.

PPD specializes in the provision of chemistry, manufacturing and controls testing across all phases of drug development, as well as offering services in the early characterization, formulation and method development through commercial release and stability testing.

According to a press release from PPD, the cell-based laboratory was initially created to address the need for development, validation and testing under established US Pharacopeial Convention, International Conference on Harmonization and US FDA current GMP guidelines. Expansion of the laboratory is to 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.

“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, Vice President of current GMP 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.”

Source: PPD expands cGMP cell-based assay laboratory.