The company recently received certification from ANVISA, Brazil’s drug regulator, “to conduct bioanalytical work on our clients’ compounds that will be marketed in Brazil,” Donna Hellsten, vice president of clinical development for the Americas for PPD, told us.
ANVISA only approves products that have had all bioavailability and bioequivalence assay work performed at a certified facility. Hellsten noted that the Brazil certification will not be valid in Chile and Mexico, which require their own bioavailability/bioequivalence certification. PPD has more than 700 employees in Latin America, with offices in Argentina, Chile, Columbia, Mexico and Peru.
In Wisconsin, meanwhile, the company has expanded its cGMP cell-based assay lab to meet the needs of clients seeking to validate bioassays for product release and stability testing of biologics and biosimilars.
“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,” Magdalena Mejillano, vice president of cGMP labs for PPD, said.
The cell lab facility will now be about 6,800 square feet to allow for broader range and increased volume of testing capabilities, including the company’s 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.
Other Recent Expansions
PPD’s moves in Brazil and Wisconsin come only a month after it expanded its central lab services in Singapore and Brussels. Those services were initially built out in the US and attracted more customers abroad and further indicate the company’s intentions in pushing their global footprint.
But whether all of this recent expansion will be enough to boost PPD’s position in the CRO industry has yet to be determined. Last October, the S&P (Standard & Poor’s) ratings services downgraded the company mostly due to higher labor costs. The S&P, however, did highlight the company’s number two position in the late services sector.