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February 19, 2025
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  Sensitive and Specific Detection of Mycoplasma DNA

Detecting mycoplasma contamination with speed, sensitivity, and precision is essential for maintaining the quality and safety of cell therapy products. This application note outlines a protocol designed to facilitate the preparation and detection of mycoplasma DNA, meeting the sensitivity requirements specified in the European Pharmacopoeia chapter 2.6.7, 'Mycoplasmas,' with test sample volumes as low as 1 mL. Download now to learn more.

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» Industry News
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  FDA Clears IND for Atopic Dermatitis Treatment
Alphyn announced that the FDA has cleared the Investigational New Drug Application (IND) for ... read more »
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  AI Powered Drug Discovery Company Appoints US Leadership Team
BluMaiden Biosciences announced the appointment of Dr. Terence Kelly as interim Chief Executive ... read more »
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  Brexogen and BMI Korea Make Transfer Agreement for Exosome Therapeutics
Brexogen announced a technology transfer and licensing agreement with BMI Korea for BxC-I17e, an ... read more »
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  Zongertinib Receives FDA Priority Review for Advanced Non-Small Cell Lung Cancer
Boehringer Ingelheim announced that the FDA has granted Priority Review to its new drug application ... read more »

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» QC Corner
QC Corner
  Streamlining Environmental Monitoring: A CMO’s Success with 3P® ENTERPRISE
This case study explores Selkirk’s journey with 3P® ENTERPRISE. Download now to learn how it ... read more »

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» Featured Articles
EVENT   Driving Innovation in Antibody Therapeutics, From Basic Research to the Clinic
Nearly 25 years after the first FDA-approved antibody-drug conjugate (ADC), the field of antibody therapeutics continues to evolve. Advances in ... read more »
EVENT   Defining VHP Sterilization and Biodecontamination – Common Denominators and Differences
VHP Applications History VHP has decades of successful use as a bio-decontamination process in the pharmaceutical industry and as a sterilization ... read more »
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» Featured Video
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  Live Webinar: How Lonza Built a Digitalized End-To-End Process for Environmental Monitoring
In this webinar learn how Lonza successfully integrated the MODA-EM® Module with Rapid Micro Biosystems' Growth Direct®System, combining paperless ... watch »
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  Explore SGS’s Comprehensive Biologics Testing Capabilities
SGS offers comprehensive GMP Testing Solutions to support all phases of biologics development from molecule to market through complex method ... watch »

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» Featured Products
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  Genome Portal
ATCC The ATCC Genome Portal offers an interactive platform to browse and download thousands of high-... learn more »
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  AeroTrak+ Remote Airborne Particle Counters
TSI Incorporated AeroTrak®+ Remote Airborne Particle Counters (APCs) offer cleanroom professionals top-notch ... learn more »
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  Bettersizer 2600 Particle Size and Shape Analyzer (DIA+LD)
Bettersize Instruments The Bettersizer 2600 utilizes proven Laser Diffraction (LD) Technology to measure particle sizes ... learn more »

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» Featured Whitepaper
EVENT   Optimizing Pyrogen Testing of Intravenous Immunoglobulins (IVIG) with the Monocyte Activation Test
A new application note, based on Lonza’s webinar with Dr. Marijke Molenaar-de Backer, covers key differences in IVIG formulations and how to navigate complex matrices with the Monocyte Activation Test... read more »
EVENT   Improving ISR Success Rates in Bioanalysis of Small Molecule Drugs
During clinical trials, Incurred Sample Reanalysis (ISR) is a powerful tool to support regulatory compliance and data integrity, bolster confidence in pharmacokinetic and pharmacodynamic modeling, and... read more »

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» More Products
AccuSizer SIS Liquid Particle Counter System Learn More
AccuSizer FX-Nano AD Particle Analyzer System Learn More
Bettersizer 2600 Particle Size and Shape Analyzer (DIA+LD) Learn More
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| Events
EVENT
  4th mRNA Analytical Development & Quality Control Summit
Boston, Massachusetts –  02/25/2025
Excitement for mRNA therapeutics continues as RNA technologies are awarded the Nobel Prize for the second year running. Yet, despite optimized ...
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EVENT
  INTERPHEX 2025
Javits Center –  04/01/2025
INTERPHEX is the leading global pharmaceutical and biotechnology event that fuses industry innovation with expert led conference. Taking place at the ...
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