American Pharmaceutical News In Review

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November 22, 2024

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White Paper: Drivers of Implementation of Recombinant Technologies for Endotoxin Testing

As documented by the most recent US Pharmacopeia announcement, the adoption of recombinant technologies for endotoxin testing is gaining momentum in the pharmaceutical industry. This article explores the fundamentals of using recombinant Cascade Reagents (rCR), their analytical performance and equivalency to LAL reagents, current developments within the regulatory framework (specifically updates provided by the USP and the factors accelerating their implementation), and more. Download this white paper to learn more.

	Industry News

FDA Approves Kedrion's Bolognana, Italy Facility for Production of Treatment for PLGD-1
Kedrion Biopharma Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has ... read more »

Amneal Resubmits DHE Autoinjector NDA and Receives FDA Approval of Exenatide, a Generic Injectable GLP-1 Agonist
Amneal Pharmaceuticals, Inc., a global pharmaceutical company, today announced the advancement of ... read more »

Health Canada Authorizes CARVYKTI® for Patients with Relapsed or Refractory Multiple Myeloma
Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance (NOC) for ... read more »

Halozyme Withdraws Proposal to Acquire Evotec
Halozyme Therapeutics, Inc. announced it has withdrawn its non-binding proposal to acquire Evotec SE... 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 »

	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

		What is This Thing Called Science and Who or What Owns It? In recent years the word “science” has been used more often by more people than at any other time of our lives. We and those reading this work in a ... read more »

		Evaluating Rapid Microbial Methods: A Comprehensive Approach to Testing with Microorganisms In the ever-evolving landscape of microbiology and quality control, Rapid Microbial Methods (RMMs) have emerged as powerful tools for detecting and ... read more »

	Featured Video

Watch Video: How Charles River Uses Pharma 4.0
In this interview at PDA Micro, hear from David Leroux-Peterson as he discusses how Charles River uses Pharma 4.0. watch »

Watch Video: How Modern Methods Help Reduce Time to Results
Hear from Jon Kallay as he discusses how modern methods help reduce time to results. watch »

	Featured Products

Mini-Uniprep™ Syringeless filters
Cytiva Transform your HPLC and UHPLC sample preparation with our Mini-UniPrep™ syringeless filters. These ... learn more »

Cell-IQ MCO 170AICUVHL-PA Incubator
PHC PHCbi brand's Cell-IQ™ CO2 incubators with capacities of 5.8 and 8.1 cu.ft. incorporate a patented ... 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 »

	Featured Whitepaper

eBook: Mastering Advanced Cell Cultures with Superior Media and Live-Cell Insights
This eBook explores the vital role of media in reliable, reproducible cell maintenance, including the challenges of developing 3D cell models. read more »

How AstraZeneca is Overcoming Obstacles to Analytical Data Access
When scientists at AstraZeneca embarked on their analytical data management journey, the primary goals were to reduce repeat experiments through data accessibility. Read how they integrated ~200 ... read more »

	More Products

AccuSizer Mini LE System Learn More
Pyros Kinetix Flex Incubating Kinetic Tube Reader Learn More
Mobius® Power MIX 100, 200, 500 L HDPE single-use mixing systems Learn More

	Directory Categories

Excipient Search Search More

Automated Sample Dilution Equipment Search More

Pharmaceutical HPLC Instruments Search More

	Events

3rd Annual PAT & Real Time Quality Summit
Philadelphia, PA – 12/11/2024
With drug developers and manufacturers facing closer scrutiny on product quality than ever before, it’s time to make the most of evolving process ... event details »

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