American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

December 09, 2024

Newsletter Sponsor

White Paper: Drivers of Implementation of Recombinant Technologies for Endotoxin Testing

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, current developments within the regulatory framework (specifically updates provided by the USP and the factors accelerating their implementation), and more. Download this white paper to learn more.

	Industry News

First FDA-Approved Treatment for Severe Frostbite Now Commercially Available in the US
SERB Pharmaceuticals announced that Aurlumyn™ (iloprost) Injection, the first FDA-approved treatment... read more »

AstraZeneca’s Datopotamab Deruxtecan Granted Breakthrough Therapy Designation
Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US ... read more »

FDA Issues Final Guidance on Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of BIMO Inspections for CDER Submissions
The FDA has issued a final guidance, Standardized Format for Electronic Submission of NDA and BLA ... read more »

BioAge Labs Ends Phase 2 Clinical Trial Evaluating Azelaprag in Combination with Tirzepatide for the Treatment of Obesity
BioAge Labs announced that the company has made the decision to discontinue the ongoing STRIDES ... read more »

	QC Corner

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 ... read more »

	Cell and Gene Therapy Circuit

Advances in Electroporation Technology: Cell & Gene Therapy Development Innovations from MaxCyte
Join Mike Auerbach, editor-in-chief at American Pharmaceutical Review and Debra Barberini, PhD, ... 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

		Why Multimodal Data is Growing In Pharma Today’s research and development (R&D) pipelines are increasingly diverse, encompassing a broad range of modalities, including antibodies, proteins ... 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

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 »

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 »

	Featured Products

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 »

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 »

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

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 »

	Directory Categories

Excipient Search Search More

Pharmaceutical Tablet Press Machines Search More

Pharmaceutical Vial Filling Machine and Equipment 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 »

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