American Pharmaceutical News In Review

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February 05, 2025

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Infographic: Pharmaceutical Sterility Testing

Rapid sterility testing technologies are revolutionizing pharmaceutical quality control by significantly reducing TTD and TTR, providing economic benefits, improving patient safety and more. This infographic details the benefits of rapid testing methods.

	Industry News

Valneva Receives UK Marketing Authorization for Chikungunya Vaccine
Valneva SE has been granted marketing authorization in the United Kingdom (UK) for the world’s first... read more »

Ovarian Cancer Drug Receives FDA’s Regenerative Medicine Advanced Therapy (RMAT) Designation
Gradalis, Inc., announced that the FDA has granted the company’s personalized investigational ... read more »

FDA Accepts Antibody Binding Specificity Test Qualification Plan Advancing Platform for Approval as a Drug Development Tool
Integral Molecular announced that the FDA has accepted their Membrane Proteome Array™ (MPA) ... read more »

Astellas Submits NDA for Conditional Approval of Avacincaptad Pegol for Geographic Atrophy in Japan
Astellas Pharma Inc. announced the submission of a New Drug Application (NDA) to Japan's Ministry of... 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

Next-Gen Sequencing in Cell and Gene Therapy Testing Services: Innovations from Eurofins BioPharma Product Testing
Learn how Eurofins is not only integrating NGS into its cell and gene therapy workflows, but also ... read more »

	Infographic

Using the Carcinogenic Potency Categorization Approach (CPCA) to Classify N-nitrosamine Impurities
This infographic details the features and benefits of selecting appropriate NDSRI reference samples. read more »

	Featured Articles

		Navigating Global Expansion: Optimizing Local QPPVs And Regulatory Lifecycle Management for Mid-Size Pharma As mid-sized pharmaceutical companies expand globally, they face growing challenges. For example, the lack of global harmonization of post-approval ... read more »

		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 »

	Featured Video

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 »

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 »

	Featured Products

IND-Enabling Testing
WuXi AppTec One of the most common challenges for drug developers pursuing global IND submissions is ... learn more »

OMNIS NIR Analyzer
Metrohm USA The OMNIS NIR Analyzer series consists of modern, Swiss-made laboratory instruments for quality ... learn more »

	Featured Whitepaper

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 »

PyroCell® MAT Rapid Systems - Quick Start Guide
For over 30 years, Lonza has supported QC testing for endotoxins and pyrogens. Our portfolio now includes two PyroCell® MAT Rapid Systems with optimized reagents for sensitive pyrogen detection. ... read more »

	More Products

AT70 smart with BS60 - Fully Automated Dissolution System for USP Learn More
FT 2 Tablet Friability Tester Learn More
Nexera UC Analytical SFC Learn More

	Directory Categories

Dissolution Instruments Search More

Analytical Instrumentation Search More

Pharmaceutical Friability Testers Search More

	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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