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February 18, 2025

Newsletter Sponsor

Product Sterility Testing in Half the Traditional Time
Sponsored by Nelson Labs
Product sterility testing ensures the safety of products by detecting microbial contamination. Per the traditional compendial methodology described in USP <71>, product samples are incubated in growth media for 14 days. However, for many products, there is the option of sterility testing using rapid microbiological methods. Rapid sterility testing using Celsis Advance II™ technology can deliver the incubation results in approximately 6 days. Learn more.

	Industry News

FDA Approves OSPOMYV™ and XBRYK™ Biosimilars to Prolia and Xgeva
Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved ... read more »

BLA Accepted for Proposed Biosimilar to Eylea®
Alvotech and Teva Pharmaceuticals announced that the FDA has accepted for review a Biologics License... read more »

FDA Accepts Gilead’s NDAs for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
Gilead Sciences, Inc. announced that the FDA has accepted its New Drug Application (NDA) submissions... read more »

FDA Approves ROMVIMZA™ for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
Ono Pharmaceutical Co. announced that the FDA)has approved ROMVIMZATM (vimseltinib), a kinase ... read more »

	QC Corner

USP 86: Bacterial Endotoxins Testing Using Recombinant Reagents
This video covers the impact of the adoption of rCR for product testing, how potential hurdles can ... read more »

	Cell and Gene Therapy Circuit

Sensitive and Specific Detection of Mycoplasma DNA
This application note outlines a protocol designed to facilitate the preparation and detection of ... read more »

	Infographic

Pharmaceutical Sterility Testing
This infographic explores the drawbacks to traditional methods and the ways in which rapid testing methods are revolutionizing pharmaceutical ... read more »

	Featured Articles

		Executive Q&A: Automated Microbiological QC Workflows Will Likely Become Commonplace Anne Weeks and Anke Hossfeld share insights on why and how automation and robotics will change microbiological QC in pharmaceutical manufacturing. read more »

		Automating Submission Compilation and Review: The Next Challenge for Regulatory GenAI Generative AI (GenAI) is not a theoretical game-changer in life sciences; the technology is already transforming everyday regulatory and safety ... read more »

	Featured Video

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 »

Improve Your Microbial QC Testing Efficiency
Join us for an exciting webinar where we'll showcase how precisely quantitated MicroQuant™ products can revolutionize your microbial QC testing. Our ... watch »

	Featured Products

Lab Incubator for Cell Culture
PHC The PHCbi Cell-IQ™ CO2 Laboratory Incubator MCO-170AICUVHLPA is a sophisticated cell culture ... learn more »

Genome Portal
ATCC The ATCC Genome Portal offers an interactive platform to browse and download thousands of high-... learn more »

AeroTrak+ Remote Airborne Particle Counters
TSI Incorporated AeroTrak®+ Remote Airborne Particle Counters (APCs) offer cleanroom professionals top-notch ... learn more »

	Featured Whitepaper

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 »

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 »

	More Products

8900 Triple Quadrupole ICP-Mass Spectrometer Learn More
Bettersizer ST - Particle size Analyzer Learn More
ExPERT ATx™ Electroporation System Learn More

	Directory Categories

Excipient Search Search More

Pharmaceutical Particle Size Analyzers Search More

Pharmaceutical Bioreactors and Fermentors Search More

	Events

Bio-IT World Conference & Expo
Boston, Massachusetts – 04/02/2025
Bio-IT World Conference & Expo is the premier global event showcasing technologies and analytic approaches that solve problems, accelerate science, ... event details »

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 ... event details »

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