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WILMINGTON, N.C. ~ Thermo Fisher Scientific Inc., the world leader in serving science, has announced the expansion of its PPD clinical research business with the addition of mycoplasma and biosafety testing capabilities at its good manufacturing practices (GMP) lab in Middleton, Wisconsin. This new service, offered by the analytical testing service of the clinical research business, aims to ensure that biopharmaceutical products are free of contaminants, ultimately delivering safe medicines to patients.
According to Sebastian Pacios, M.D., senior vice president and president of clinical research at Thermo Fisher Scientific, this expansion further strengthens their ability to help customers make the world healthier and solidifies their leadership in this important area. He also notes that there is a growing global need for biosafety testing, especially with the discovery of new cell and gene therapy targets and the expansion of treatments. By adding biosafety testing to their portfolio, Thermo Fisher can provide a comprehensive solution for their GMP lab customers and accelerate the full panel of tests to deliver life-changing therapies as quickly as possible.
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Mycoplasmas are one of the smallest known free-living organisms and can be difficult to detect in mammalian cell cultures. To ensure product quality and patient safety, organizations follow GMP guidelines and strict risk mitigation plans to detect mycoplasmas early on. This not only helps avoid costly delays or remediation but is also a regulatory requirement for lot-release testing. The traditional mycoplasma testing method can take up to a month to generate results. However, with the new quantitative polymerase chain reaction (qPCR) version that incorporates nucleic acid testing, results can now be obtained within five days. This faster turnaround time has led to a 50% utilization rate and is prompting more organizations to switch over to nucleic acid testing.
The rise in chronic diseases such as cancer, neurological disorders, and heart disease has resulted in 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 due to its accuracy, speed, and flexibility, allowing for quick delivery of medicines to patients.
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The PPD Laboratory services team's GMP lab in Middleton offers fully integrated solutions for pharmaceutical product development. This includes method development and validation, compendial verifications, stability testing, quality control and release testing. The lab also specializes in biologics testing such as cell and gene therapy product development and is a market leader in the analysis of small molecule, inhalation products, medical device functionality testing, as well as extractables and leachables testing.
Apart from the GMP and bioanalytical labs in Middleton, Thermo Fisher's clinical research business also 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; as well as bioanalytical, biomarker, vaccine sciences and central labs in Suzhou China.
With this expansion of services at their GMP lab in Middleton and their global presence in various areas of clinical research and testing capabilities,Thermo Fisher Scientific continues to solidify its position as a leader in serving science and helping customers deliver safe medicines to patients worldwide.
According to Sebastian Pacios, M.D., senior vice president and president of clinical research at Thermo Fisher Scientific, this expansion further strengthens their ability to help customers make the world healthier and solidifies their leadership in this important area. He also notes that there is a growing global need for biosafety testing, especially with the discovery of new cell and gene therapy targets and the expansion of treatments. By adding biosafety testing to their portfolio, Thermo Fisher can provide a comprehensive solution for their GMP lab customers and accelerate the full panel of tests to deliver life-changing therapies as quickly as possible.
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Mycoplasmas are one of the smallest known free-living organisms and can be difficult to detect in mammalian cell cultures. To ensure product quality and patient safety, organizations follow GMP guidelines and strict risk mitigation plans to detect mycoplasmas early on. This not only helps avoid costly delays or remediation but is also a regulatory requirement for lot-release testing. The traditional mycoplasma testing method can take up to a month to generate results. However, with the new quantitative polymerase chain reaction (qPCR) version that incorporates nucleic acid testing, results can now be obtained within five days. This faster turnaround time has led to a 50% utilization rate and is prompting more organizations to switch over to nucleic acid testing.
The rise in chronic diseases such as cancer, neurological disorders, and heart disease has resulted in 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 due to its accuracy, speed, and flexibility, allowing for quick delivery of medicines to patients.
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The PPD Laboratory services team's GMP lab in Middleton offers fully integrated solutions for pharmaceutical product development. This includes method development and validation, compendial verifications, stability testing, quality control and release testing. The lab also specializes in biologics testing such as cell and gene therapy product development and is a market leader in the analysis of small molecule, inhalation products, medical device functionality testing, as well as extractables and leachables testing.
Apart from the GMP and bioanalytical labs in Middleton, Thermo Fisher's clinical research business also 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; as well as bioanalytical, biomarker, vaccine sciences and central labs in Suzhou China.
With this expansion of services at their GMP lab in Middleton and their global presence in various areas of clinical research and testing capabilities,Thermo Fisher Scientific continues to solidify its position as a leader in serving science and helping customers deliver safe medicines to patients worldwide.
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