The PPD clinical research business of Thermo Fisher Scientific Inc. 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.”
 
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 aims to be a 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.