American Pharmaceutical News In Review

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January 06, 2025

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eBook: Principles of Bioburden Testing

The importance of bioburden testing in pharmaceutical manufacturing cannot be overstated because of the impact it has in ensuring patient safety. This eBook covers automation in bioburden testing, aligning automated bioburden testing and regulatory policy, the impact of USP, and more.

	Industry News

BMS Announces Positive Topline Results from Two Phase 3 Trials Evaluating Sotyktu in Adults with Psoriatic Arthritis
Bristol Myers Squibb announced results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), ... read more »

Eton Pharmaceuticals Acquires Rare Disease Treatment Galzin®
Eton Pharmaceuticals, Inc. announced that it has acquired Galzin® (zinc acetate). “This acquisition... read more »

TEVIMBRA Approved in U.S. for First-line Treatment of Gastric and Gastroesophageal Junction Cancers
BeiGene, Ltd. announced the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (... read more »

Immedica to Acquire Marinus Pharmaceuticals
Immedica Pharma AB and Marinus Pharmaceuticals, Inc. announced that they have entered into an ... read more »

	QC Corner

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 ... read more »

	Cell and Gene Therapy Circuit

Cell and Gene Therapy Analytical Testing Considerations: Innovations from Thermo Fisher Scientific
Topics covered include key analytical testing considerations that are unique to cell and gene ... 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

		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 »

		Real Time Analytics Implementation in Continuous Manufacturing Process monitoring and control support the maintenance of a state of control during production and allow real-time evaluation of system performance. ... 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: 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 »

	Featured Products

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

BioTrak® Real-Time Viable Particle Counter
TSI Incorporated Isolators are designed to keep operators out and sterile product safe. Nevertheless, traditional ... 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 »

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

EMCOCEL® 90M - Microcrystalline Cellulose Learn More
TPW Tablet Processing Workstation Learn More
BioFlo®/CelliGen® 115 Benchtop Fermentor & Bioreactor Learn More

	Directory Categories

Excipient Search Search More

Pharmaceutical Inspection Search More

Pharmaceutical Incubators Search More

	Events

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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