PPD clinical research business provides lab customers a comprehensive solution to help ensure safe medicines for patients

The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, is adding mycoplasma and additional biosafety testing capabilities to its expanding portfolio of services at its good manufacturing practices (GMP) lab in Middleton, Wisconsin. This new service, offered by the analytical testing service of the clinical research business, ensures biopharmaceutical products are free of contaminants, helping customers deliver safe medicines for patients.

“The continuing expansion of our GMP lab to include these new services further strengthens our ability to help our customers make the world healthier and helps advance Thermo Fisher’s leadership in this important area,” said Sebastian Pacios, M.D., senior vice president and president, clinical research, Thermo Fisher Scientific. “There is a growing need globally for biosafety testing, including for new cell and gene therapy targets being discovered and as treatments expand. Adding biosafety testing offers a comprehensive solution for our GMP lab customers, providing them a single-location solution to accelerate the full panel of tests and ultimately deliver life-changing therapies as quickly as possible.”

Mycoplasmas – some of the smallest known free-living organisms – are difficult-to-detect bacterial contaminants in mammalian cell cultures. Organizations follow GMP guidelines and stringent risk mitigation plans to detect mycoplasmas early, ensure product quality and patient safety, and avoid costly delays or remediation. For lot-release testing, regulatory guidance requires that all products derived from mammalian cell culture be tested for mycoplasma.

Traditional mycoplasma testing can take a month or more to generate results. The new quantitative polymerase chain reaction (qPCR) version, which incorporates nucleic acid testing, currently has grown to a 50% utilization rate that enables results to be obtained within five days, a much faster turnaround that helps accelerate the manufacturing process and continues to prompt conversion to nucleic acid testing.

The rise in chronic diseases such as cancer, neurological disorders and heart disease has led to an increased demand for drugs, cell therapies, diagnostics and other biological products. To ensure their safety, regulatory requirements mandate testing for the presence of pathogens, including mycoplasma. This has led to a growing demand for mycoplasma testing products. Nucleic acid analysis is the preferred method for this testing because of its accuracy, speed and flexibility, allowing for quick delivery of medicines to patients.

The PPD Laboratory services team’s GMP lab in Middleton offers fully integrated solutions for pharmaceutical product development, including method development and validation, compendial verifications, stability testing, quality control and release testing. The lab also provides biologics testing, including cell and gene therapy product development, and is a market leader in the analysis of small molecule, inhalation products and medical device functionality testing, as well as extractables and leachables testing.

In addition to GMP and bioanalytical labs in Middleton, Thermo Fisher’s clinical research business includes bioanalytical, biomarker and vaccine sciences labs in Richmond, Virginia; a GMP lab in Athlone, Ireland; central labs and biomarker operations in Brussels, Belgium, Highland Heights, Kentucky, and Singapore; and bioanalytical, biomarker, vaccine sciences and central labs in Suzhou, China.