American Pharmaceutical News In Review

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November 20, 2024

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How Mass Spectrometry Delivers Accurate Identifications
Sponsored by Nelson Labs
Drug substances and drug products require continuous monitoring for impurities. A mass spectrometry approach that is comprehensive is the key to identifying unexpected impurities. This approach includes the combination of high-resolution accurate mass spectrometry with tandem mass spectrometry. In a recent webinar one of our senior mass spectrometry experts discusses this comprehensive approach and reviews some case studies. Learn more.

	Industry News

FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development
The FDA has published a new batch of product-specific guidances (PSGs). PSGs provide recommendations... read more »

Remedy Pharmaceuticals Receives FDA Guidance to Advance CIRARA for Treatment of Severe Stroke
Remedy Pharmaceuticals announced that a Type C meeting held with the FDA on October 16, 2024, ... read more »

Bristol-Myers Squibb Canada Wins The 2024 Prix Galien Innovative Product Award
Prix Galien Canada is announced that Bristol-Myers Squibb Canada, Co. is the recipient of the ... read more »

FDA Orphan Drug Designation Given to ALS Treatment
Ractigen Therapeutics announced that the FDA granted Orphan Drug Designation (ODD) to RAG-21, its ... read more »

	QC Corner

Disinfect, Autoclave or Use Multiple-Bagged Disposables? Moving Materials into Controlled Areas Safely and Efficiently
Transferring equipment into and out of cleanrooms and critical zones has proven to be one of the ... read more »

	Cell and Gene Therapy Circuit

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 ... 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 »

		Executive Q&A: SGS’ Hudson, NH Bioanalytical Services Facility SGS established the bioanalytical testing facility in Hudson, NH, as part of its strategic effort to broaden our scope of testing solutions offered in... 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

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

BASF Virtual Pharma Assistants
BASF North America Save time and avoid costly missteps with the BASF Virtual Pharma Assistants, your interactive ... learn more »

QUALIS UV Laser Printer
Qualicaps As a pioneer in capsule and tablet manufacturing, Qualicaps has accumulated a wealth of expertise ... 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 »

From Donor to Drug: The Essential Role of Human Panel Testing in Allogeneic Therapies
The advent of allogeneic cell-based therapies has led to a significant shift within the pharmaceutical industry. These therapies rely upon cells derived from non-patient donors to be used as raw ... read more »

	More Products

AccuSizer Mini FX System Learn More
Cary 3500 Compact UV-Vis Spectrophotometer Learn More
Discovery SA Dynamic Vapor Sorption Analyzer Learn More

	Directory Categories

Excipient Search Search More

Pharmaceutical Bioreactors and Fermentors Search More

Pharmaceutical Infrared Spectrometers 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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