US-based contract research organization (CRO) Pharmaceutical Product Development (PPD) is expanding its cGMP cell-based assay laboratory in Middleton, Wisconsin, US.
The cell lab facility has been added with an approximate 6,800ft² space, which will allow the company to conduct a much broader range and increased volume of testing capabilities.
The firm claims that the expansion aims 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 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’s Middleton cell lab will now support a greater volume of bioassay development, validation and testing projects and provide a wide range of product testing capabilities.
PPD cGMP labs vice president Magdalena Mejillano said biotech and pharmaceutical companies are shifting their strategies to developing high-value, niche therapies utilizing biologics, a trend that is expected to generate major growth in characterization of biologics, as well as biosimilars.
"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," Mejillano added.