American Pharmaceutical News In Review

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September 14, 2023

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Faster, Simpler, and More Sustainable Endotoxin Testing

Perform fully compliant BET assays with fewer than 30 pipetting steps in just minutes! The Sievers Eclipse BET platform is user-friendly, offers streamlined training and validation, and uses only a fraction of the consumables that traditional methods require. From pre-embedded RSE, significantly fewer pipetting tips, and up to 90% less LAL needed to perform assays, the Sievers Eclipse allows labs around the world to reduce their footprint without sacrificing operational efficiency or compliance.

	Industry News

FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products
The FDA issued warning letters to eight companies for manufacturing or marketing unapproved ... read more »

Deloitte Digital and Salesforce Join Forces to Accelerate Innovation for the BioPharma Industry
Deloitte Digital and Salesforce announced plans to accelerate CRM innovation for the BioPharma ... read more »

ABL Bio Taps into Synaffix ADC Technology to Accelerate Development of Bispecific ADC Products
Synaffix, a Lonza company focused on commercializing its clinical-stage platform technology for the ... read more »

Devyser and Thermo Fisher Scientific Collaborate to Promote Laboratory Services to Advance Pharmaceutical Research
Devyser and Thermo Fisher Scientific entered an agreement to promote laboratory services. read more »

	QC Corner

QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more »

	Infographic

Data Integrity in Pharmaceutical Quality Control
This infographic gives an overview on important terms and definitions, points of compliance, and ways to achieve quality control and data integrity. read more »

	Featured Articles

		Origin and Application of the 50-200% Range in the Bacterial Endotoxins Test Laboratory analysts who have been performing compendial Bacterial Endotoxins testing (BET) for a number of years have come to accept the idea that the... read more »

		Understanding and Resolving Drug Shortages in the Pharmaceutical Industry People undergoing treatment for attention deficit/hyperactivity disorder (ADHD), certain cancers, various infectious diseases, and pain management may... read more »

	Featured Video

On-Demand Webinar: Container Closure Requirements: Preparing for USP 382, 661.1, and 661.2
Container closures are critical to ensure sterility of drug products. Physical, chemical, and biological assessments must be made to ensure components... watch »

The Pharma Flash - Acquisitions, Approvals and New Product Launches
Watch Video: In this week’s Pharma Flash – J&J’s prostate cancer drug approved by FDA and Novartis completes acquisition of Chinook Therapeutics, plus... watch »

	Featured Products

Lasair Pro
Particle Measuring Systems The Lasair Pro supports a complete contamination control solution including clean area monitoring (... learn more »

Aquarius™ TF Film Coating System
Ashland Inc. Aquarius™ TF film coating system provides superior opacity, brightness and aesthetics to tablets ... learn more »

ExPERT STx™ Electroporation System
MaxCyte, Inc The industry’s leading scalable electroporation technology for high-yield, transient expression of ... learn more »

	Featured Whitepaper

Article: Addressing Challenges with Clinical In-Use Testing of Biotherapeutics
Lonza Drug Product expert Léa Sorret PhD explores Clinical In-Use Testing of Biotherapeutics in this white paper. Lea shares her expertise and describes the key elements to support superior product ... read more »

Whitepaper: Use of Laboratory Balances in the Pharmaceutical Industry
Pharmacopoeias are collections of recognized and binding quality regulations that specify, among other things, test requirements and methods for the analysis of drugs. Both the European Pharmacopoeia... read more »

	More Products

BENCHTOP Manifold Freeze Dryer Learn More
BIOne 1250 Bioprocess Control Station Learn More
COMPRIMA 300 Tablet Press Learn More

	Directory Categories

Bioprocessing Search More

Pharmaceutical Chiller Systems Search More

Pharmaceutical Excipients Search More

	Events

Global Bioprocessing Summit
Berlin, Germany – 11/16/2023
The industry, professionals, and scientists are actively seeking methods to delineate more precise guidelines and anticipated requirements for ... event details »

Bio-IT World Conference & Expo Europe
London, England – 11/29/2023
Bio-IT World Conference & Expo Europe unites a community of leading life sciences, pharmaceutical, clinical, healthcare, informatics, and technology ... event details »

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