American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

February 03, 2025

Newsletter Sponsor

Preparing for New Container Closure Integrity (CCI) Testing Requirements
Sponsored by Nelson Labs
Container closure integrity is critical for the sterility and stability of drug products, and new USP requirements will result in changes to CCI testing. This webinar reviews the changes that these new requirements will bring. Or for an abbreviated version, you can read the whitepaper. Learn more.

	Industry News

FDA Clears IND for the UKidney Xenotransplantation Clinical Trial
United Therapeutics Corporation announced that the FDA has cleared its Investigational New Drug ... read more »

Opdivo Receives Positive CHMP Opinion for Hepatocellular Carcinoma
Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the... read more »

Vanda Pharmaceuticals and Anaptys to Develop and Commercialize Imsidolimab
Vanda Pharmaceuticals Inc. and AnaptysBio, Inc. announced an exclusive, global license agreement for... read more »

Baxter Kidney Care Rebrands as Vantive
Vantive, formerly the Baxter Kidney Care segment, has launched as a new standalone vital organ ... 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

Next Generation Sequencing for Cell and Gene Therapy
Download this white paper to learn how NGS provides high quality, regulatory-accepted results to ... read more »

	Infographic

Pharmaceutical Sterility Testing
This infographic explores the drawbacks to traditional methods and the ways in which rapid testing methods are revolutionizing pharmaceutical ... 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 »

		As Prototypes Are Refined into Standardized Solutions, It Is Time to Consider Robotics and Automation in Microbial QC At a time when the pharmaceutical industry is entering a new transformational phase, the promise that automation, robotics, and concomitant ... read more »

	Featured Video

USP 86: Bacterial Endotoxins Testing Using Recombinant Reagents
This video covers the impact of the adoption of rCR for product testing, how potential hurdles can be streamlined for labs, the essential validation ... watch »

Improve Your Microbial QC Testing Efficiency
Join us for an exciting webinar where we'll showcase how precisely quantitated MicroQuant™ products can revolutionize your microbial QC testing. Our ... watch »

	Featured Products

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

GMPs for Early Stage Development Projects
This whitepaper, produced by Regulatory Compliance Associates (RCA), a Nelson Labs company, discusses the benefits of applying Good Manufacturing Practices (GMPs) to pharmaceutical development phases.... read more »

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 »

	More Products

Model 2500 Water Bath Dissolution System Learn More
AdvaTab Orally Disintegrating Tablet Technology Learn More
Axcess® MALDI-TOF for Microbiology Identification Learn More

	Directory Categories

Dissolution Instruments Search More

Pharmaceutical Drug Delivery Technologies Search More

Pharmaceutical Cleanroom Equipment 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 »

Bio-IT World Conference & Expo
Boston, Massachusetts – 04/02/2025
Bio-IT World Conference & Expo is the premier global event showcasing technologies and analytic approaches that solve problems, accelerate science, ... event details »

This information is being brought to you because you are a subscriber to
American Pharmaceutical Review. To ensure delivery to your inbox,
please add newsletters@americanpharmaceuticalreview.com to your address book.

Manage your Subscription | Unsubscribe | Contact American Pharmaceutical Review

American Pharmaceutical Review
164 Townsend St. Unit 2
San Francisco, CA 94107 USA