Trending...
- RAS AP Consulting Expands Managed AP Governance™ Ecosystem, Launches Trademark Process, and Secures IFOL Speaker Invitation
- UK Financial Ltd Makes History: Chainlink CRE Circulating Supply Verification Goes Live Across Its Complete Ecosystem Of Nine Exchange-Traded Tokens
- FDA Clears Major Regulatory Hurdle as Preservative-Free Ketamine Program Moves Within Reach of Commercialization: NRx Pharmaceuticals: (NAS DAQ: NRXP)
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.
More on ncarol.com
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.
More on ncarol.com
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.
More on ncarol.com
- Move in this Fall! New Released Quick Move-In Townhomes at Heritage at South Brunswick with Limited-Time Incentives
- Crossroads4Hope Marks 25 Years Ensuring No One Faces Cancer Alone At its Inspiring Hope Gala
- Q1 2026 Arizona Technology Industry Impact Report Recaps Advanced Manufacturing Growth, High-Value Jobs and Workforce Investment
- Former Prosecutor Opens Stegall Law in Summerville
- Vboost Celebrates 14 years of Automotive Viral Marketing
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.
More on ncarol.com
- EXETR Exteriors Unveils XOS — Proprietary Roofing Project Management Platform
- Ignazio Arces Wins Stevie® Award for Maverick of the Year at the 2026 International Business Awards
- New from Regal House, The Great Awakening: dark comic vision of a split nation veering off the rails
- Tickeron Highlights AI Trading Agent Performance Across Multiple Market Sectors
- Stop Bleeding Cash on Mediocre Talent. Build a Powerhouse Remote Team Instead
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.
Filed Under: Business
0 Comments
Latest on ncarol.com
- PricZone Launches Online Shopping Platform Offering Electronics, Gaming, and More
- Heritage at South Brunswick Introduces New Ferndale Floorplan: The Largest Single-Family Home Design in the Community
- Lineus Medical Elevates Leadership to Accelerate Growth After Breakthrough Clinical Results
- Gateway Center Arena Announces Duane Curry as General Manger
- New from Regal House Publishing, The Parliament of Mice, classic animal fables retold as satires
- XRPPower Expands Platform Security With Enhanced Brand Protection and Official Verification Standards
- Cuvo Health, the #1 White Label Telehealth Platform, Surpasses 300 Exclusive Providers Serving All 50 States
- RAS AP Consulting Expands Managed AP Governance™ Ecosystem, Launches Trademark Process, and Secures IFOL Speaker Invitation
- UK Financial Ltd Makes History: Chainlink CRE Circulating Supply Verification Goes Live Across Its Complete Ecosystem Of Nine Exchange-Traded Tokens
- International Rights Groups Raise Alarm Over Freedom of Religion and Expression in South Korea
- The City's Most Elegant Open-Air Dinner Party Returns September 12, 2026
- FDA Clears Major Regulatory Hurdle as Preservative-Free Ketamine Program Moves Within Reach of Commercialization: NRx Pharmaceuticals: (NAS DAQ: NRXP)
- Autonomous Robotics Platform Expansion as Public Market Debut is Very Close: MBody AI Corp. (N A S D A Q: MBAI)
- New Book gives Consumer Goods Leaders a Governance Playbook for Generative and Agentic AI
- Loud! OOH calls for prize draw advertising standards as £1.3bn category moves outdoors
- Black Ribbon Productions Launches With Fearless 2026 Horror Slate
- Actor Dominic Pace Returns to Television and Film
- Opteamix welcomes Girish Ramachandra to its leadership team as Senior Vice President of Client Services
- Silicon Box Ships 500M Units at High Yield, Expands Production Capacity for Panel-Level Packaging
- Why Baton Rouge's Humid Climate Can Contribute to Carpenter Ant Damage — J&J Exterminating Explains How to Protect Your Home