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December 16, 2024

Newsletter Sponsor

Critical Testing to Support the Development of Your Drug Product
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For the successful development of your drug product, the necessary testing must be performed per cGMP to validate the product’s safety, quality, and efficacy. Nelson Labs performs much of the critical testing for CDMOs, which includes sterility testing through either isolators or cleanroom, container closure integrity testing, raw materials and excipients testing, and extractables and leachables testing. Additionally, we can solve challenges that are not typically addressed in routine testing. Learn more.

	Industry News

FDA Revokes EUAs for Four Monoclonal Antibody Products
At the request of the individual product sponsors, FDA has revoked the Emergency Use Authorizations ... read more »

FDA Approves CRENESSITY™ for Children and Adults With Classic Congenital Adrenal Hyperplasia
Neurocrine Biosciences, Inc. announced the FDA approved CRENESSITY™ (crinecerfont) capsules and oral... read more »

CDER Establishes New Center for Real-World Evidence Innovation
The U.S. FDA Center for Drug Evaluation and Research (CDER) announced the new CDER Center for Real-... read more »

AbbVie to Acquire Nimble Therapeutics for $200M
AbbVie and Nimble Therapeutics today announced a definitive agreement under which AbbVie will ... 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

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

		Process Capability to Ensure Product Quality Quality by Design (QbD) is a concept first developed by the quality pioneer Joseph M. Juran. Juran believed that quality should be designed into 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

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 »

	Featured Products

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 »

Mini-Uniprep™ Syringeless filters
Cytiva Transform your HPLC and UHPLC sample preparation with our Mini-UniPrep™ syringeless filters. These ... 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: Ultrapure Water for Laboratories: Comprehensive Production Techniques and Best Practices
This eBook covers comprehensive production techniques and best practices for ultrapure water in laboratories. Topics covered include choosing the right water purification system for pharmaceutical ... read more »

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 reagents, the main challenges faced by companies when transitioning from LAL to rFC testing, future trends,... read more »

	More Products

AccuSizer FX-Nano AD Particle Analyzer System Learn More
Cary 3500 Flexible UV-Vis Spectrophotometer Learn More
Discovery Differential Scanning Calorimeter 2500 Learn More

	Directory Categories

Excipient Search Search More

Pharmaceutical Bioreactors and Fermentors Search More

Pharmaceutical Particle Size Analyzers Search More

	Events

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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