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February 12, 2025

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USP 86: Bacterial Endotoxins Testing Using Recombinant Reagents

USP chapter <86> will allow the use of non-animal-derived reagents (rFC and rCR) for bacterial endotoxin testing. Users can choose traditional LAL or recombinant reagents but must validate their method per USP <1226>. This Q&A video covers questions around the impact of the adoption of rCR for product testing, how potential hurdles can be streamlined for labs, the essential validation requirements for implementing recombinant reagents in bacterial endotoxin testing, and more.

	Industry News

Celltrion's ACTEMRA® Biosimilar Gains Approval
Celltrion announced that the FDA has approved AVTOZMA® (CT-P47, tocilizumab-anoh) in both an ... read more »

FDA Approves GOMEKLI™ for the Treatment of Nervous System Tumors
SpringWorks Therapeutics, Inc. announced that the FDA has approved GOMEKLI™ (mirdametinib), ... read more »

AbbVie and Xilio Therapeutics to Develop Novel Tumor-Activated Immunotherapies in Potential $2.1B Deal
AbbVie and Xilio Therapeutics, Inc. announced a collaboration and option-to-license agreement to ... read more »

Multiple System Atrophy Treatment Receives FDA Fast Track Designation
H. Lundbeck A/S announced that amlenetug has received Fast Track designation from the FDA. read more »

	QC Corner

Disinfect, Autoclave or Use Multiple-Bagged Disposables? Moving Materials into Controlled Areas Safely and Efficiently
Transferring equipment into and out of cleanrooms and critical zones has proven to be one of the ... read more »

	Cell and Gene Therapy Circuit

Next Generation Sequencing for Cell and Gene Therapy
Download this white paper to learn how NGS provides high quality, regulatory-accepted results to ... read more »

	Infographic

Exploring Oligos and Peptides for Pharma Manufacturing
This infographic details the features and benefits of AJIPHASE technologies. Download now to learn more. read more »

	Featured Articles

		Is the Timing of the Microbial Release Testing of Drug Products Important? The authors have become aware that regulators, especially during site inspections, are beginning to ask questions about whether pharmaceutical ... read more »

		Shifting Sands: From Sensitivity to Accuracy in Bioanalysis In recent years, regulatory focus has notably shifted from sensitivity to accuracy, underscoring a pivotal change in how we approach toxicological ... read more »

	Featured Video

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 be streamlined for labs, the essential validation ... watch »

On-Demand Webinar: Overcoming Non-Conformance Challenges with Handheld Raman Devices for Raw Material ID
Join us to learn about Spatially Offset Raman Spectroscopy (SORS) and the Agilent Vaya Raman for identifying materials through both opaque and ... watch »

	Featured Products

JCF-100 Fully Automatic Auger Capsule Filling Machine
Qualicaps As a pioneer in capsule manufacturing, Qualicaps has accumulated a wealth of know-how and ... learn more »

VACUUBRAND® VACUU-PURE® 10C Chemically Resistant Dry Screw Pump
BRANDTECH® Scientific The VACUU·PURE® 10C dry screw pump reliably delivers the benefits of oil-free vacuum technology in ... learn more »

	Featured Whitepaper

Whitepaper: Reducing risk in HPLC/LC-MS therapeutic drug treatment and monitoring
This white paper explores the critical role of ultrapure water in HPLC and LC-MS/MS, focusing on key clinical diagnostic applications. It examines water quality-related challenges in ISD monitoring, ... read more »

Sievers* Eclipse BET Platform Recombinant Reagent Analysis
This application note demonstrates compatibility of the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform with rCR across various pharmaceutical products, providing a highly efficient, ... read more »

	More Products

TSQ Vantage Triple Stage Quadrupole Mass Spectrometer Learn More
Laser Aerosol Spectrometer Learn More
HS-20 Series Headspace Samplers Learn More

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	Events

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 ... 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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