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February 06, 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

Bristol Myers Squibb Expands Cost-Cutting Target to $2 Billion by 2027
Bristol Myers Squibb (BMS) has announced an expansion of its ongoing cost-cutting initiative, aiming... read more »

Henlius and Dr. Reddy's Ink Deal for HLX15 Biosimilar Expansion in Europe and the U.S.
Shanghai Henlius Biotech, Inc. has entered into a license agreement with Dr. Reddy's Laboratories SA... read more »

Lilly Reports 45% Increase in Q4 2024 Financial Results - Provides 2025 Guidance
Eli Lilly and Company announced its financial results for the fourth quarter of 2024 and detailed ... read more »

BD to Separate Biosciences and Diagnostic Solutions Business
BD (Becton, Dickinson and Company) announced its board of directors has unanimously authorized BD ... read more »

	QC Corner

Enhancing Material and Equipment Availability in Production Isolators
Using isolators for aseptic processing is fast becoming standard practice in the pharmaceutical ... read more »

	Cell and Gene Therapy Circuit

Maximizing the Potential of 3D Organoid Research with Automated Isolation
Watch this presentation to learn more about the benefits and challenges of using automated isolation... read more »

	Infographic

Revolutionizing Bioburden Testing
Download this infographic to learn ten benefits of the Sievers Soleil Rapid Bioburden Analyzer, including comprehensive monitoring, rapid time to ... read more »

	Featured Articles

		Executive Q&A: Digitalization of Processes in the Pharmaceutical Industry Pharmaceutical companies can stay adaptable in the rapidly evolving digital landscape by embracing digitalization and leveraging data-driven ... 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

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 »

Watch Video: Partnerships to Promote Sustainability in the Pharmaceutical Microbiology Environment
In this Interview with Yvonne Bos from Charles River at PDA Micro 2024, learn about how Partnerships Promote Sustainability in the Pharmaceutical ... watch »

	Featured Products

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 »

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

	Featured Whitepaper

The Future of Endotoxin Testing: USP Chapter 86 and the Shift to Recombinant Methods
This white paper covers an overview of USP Chapter <86>, the advantages of recombinant reagents, the main challenges faced by companies when transitioning from LAL to rFC testing, future trends,... read more »

Whitepaper: From LAL to rFC Assays - A More Sustainable Future for Endotoxin Testing
Sustainability is important to Lonza and the pharmaceutical and biomedical industries and our whitepaper highlights the importance and need for sustainable approaches. It also highlights the below ... read more »

	More Products

Chromolith HPLC columns Learn More
Shim-pack Arata LC Columns Learn More
nanoACQUITY UPLC System with HDX Technology Learn More
BioSMB Multi-column Chromatography PD System Learn More

	Directory Categories

Pharmaceutical Chromatography Supplies Search More

Pharmaceutical HPLC Equipment Search 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 »

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 »

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