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December 20, 2024

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QC Corner: The Future of Endotoxin Testing: USP Chapter <86> and the Shift to Recombinant Methods

For the past 50 years, the Limulus amebocyte lysate (LAL) test has served as the foundation of drug and medical device manufacturing endotoxin control. Now, the United States Pharmacopeia (USP) has recognized the need to transition to recombinant methods in the newly published USP Chapter <86>. 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, and more.

	Industry News

Roche’s Phase IIb Study of Prasinezumab Missed Primary Endpoint – Still Shows Promise
Roche announced results from the Phase IIb PADOVA study investigating prasinezumab in 586 people ... read more »

Valneva Expands Access in Asia for its Chikungunya Vaccine with Serum Institute of India
Valneva SE announced an exclusive license agreement for Valneva’s single-shot chikungunya vaccine ... read more »

FDA Approves Methadone Hydrochloride Multi-Dose Injection
Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa International, announced that the U.S... read more »

Abilita Therapeutics and Orion Collaborate to Develop Next-Gen Antibody Therapeutics in the Areas of Oncology and Pain
Abilita Therapeutics, Inc. announced a global licensing and multi-target research collaboration with... read more »

	QC Corner

Enhanced Cleanroom Control: Modern Methods for Accurate Mold Detection
In this webinar, hear from Dr. Doug Botkin from Charles River Laboratories as he discusses Enhanced ... 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

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

		Developing Next Generation Nanoparticle Vaccines The recent COVID-19 pandemic highlighted the urgent need for effective vaccines to protect public health. Over seven million people are reported to ... 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

On-Demand Webinar: Establishing a Facility Isolate Program to Support QC Testing and Validation
Join us for a comprehensive webinar on establishing a local facility isolate program based on environmental and process monitoring microflora trending... 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

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 »

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 »

Kolliphor ® PS 20
BASF North America Kolliphor® PS 20 is an oily, yellow, clear or slightly opalescent liquid with a faint odor. ... learn more »

	Featured Whitepaper

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 »

eBook: Ultrapure Water for Laboratories: Comprehensive Production Techniques and Best Practices
This eBook covers comprehensive production techniques and best practices for ultrapure water in laboratories. Topics covered include choosing the right water purification system for pharmaceutical ... read more »

	More Products

Abbemat 200 Economy Line Refractometer Learn More
BENCHTOP Manifold Freeze Dryer Learn More
Cary 3500 Compact UV-Vis Spectrophotometer Learn More

	Directory Categories

Excipient Search 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 »

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