American Pharmaceutical News In Review

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December 04, 2024

Newsletter Sponsor

Drivers of Implementation of Recombinant Technologies for Endotoxin Testing
Sponsored by ACC
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, and current developments within the regulatory framework (specifically updates provided by the USP and the factors accelerating their implementation). Download this white paper now to learn more.

	Industry News

Samabriva Opens Large-Scale Biomanufacturing Facility in Belgium
French biotechnology company Samabriva has announced the opening of a new 1,400 m² biomanufacturing ... read more »

Martin Pharmaceuticals Secures Exclusive Rights to Docarpamine From Mitsubishi Tanabe Pharma for Chronic Liver Disease
Martin Pharmaceuticals, a clinical-stage pharmaceutical company developing CIQUAAX® (docarpamine) ... read more »

BRC-002 Receives Orphan Drug Designation from FDA for Complex Regional Pain Syndrome
Biopharmaceutical Research Company (BRC), a specialty pharmaceutical company developing proprietary ... read more »

Wave Neuroscience Receives FDA Breakthrough Device Designation for Pioneering PTSD Treatment, MeRT
Wave Neuroscience announced that its proprietary Magnetic EEG Resonance Therapy (MeRT) system has ... 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

Five Reasons Why Additive Manufacturing is Important and Beneficial for Drug Delivery
Download our latest infographic now for five reasons why additive manufacturing is important and beneficial for drug delivery. read more »

	Featured Articles

		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 »

		Lyophilization Technology for Improving Stability of Small and Large Molecules The instability of drugs constitutes a major barrier in the commercial development and manufacture of pharmaceutical products. Lyophilization, or ... read more »

	Featured Video

Analytical Testing Regulatory Requirements for Release and Stability Assessment of Biologics
In this webinar, hear from Kasia Marciniak-Darmochwal, PhD as she discusses Analytical Testing Regulatory Requirements for Release and Stability ... 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

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

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 »

	Featured Whitepaper

Compliance with Annex 1: Sterile Fill Finish for Early Phase Clinical Supplies
Stay up to date on Annex 1 requirements for sterile fill finish processes in early-phase clinical supplies. In this whitepaper, Joe Page, PH.D., President of Eurofins BioPharma Product Testing San ... read more »

Streamlining Environmental Monitoring: A CMO’s Success with 3P® ENTERPRISE
This case study explores Selkirk’s journey with 3P^® ENTERPRISE. Download now to learn how it will help Selkirk prioritize efficiency and data integrity within their environmental monitoring ... read more »

	More Products

Allegro 200 L Single-Use Mixer Learn More
Cell-IQ MCO 170AICUVHL-PA Incubator Learn More
Cary 3500 Flexible UV-Vis Spectrophotometer Learn More

	Directory Categories

Excipient Search Search More

Chromatography Cartridges Search More

Pharmaceutical Bioreactors and Fermentors 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 »

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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