American Pharmaceutical News In Review

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September 03, 2021

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Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit. If the drug product or the medical device were pure (meaning without impurities), ideally the therapeutic benefit would be largely realized with minimal adverse patient effects. However, since the practical reality is that drug products and medical devices contain impurities, a patient is exposed to these impurities during treatment and these impurities could potentially trigger an increase of adverse patient effects.

	Industry News

Aquavit's AQV-1122 COVID-19 Vaccine Patent Approval Fast Tracked by USPTO
Aquavit Pharmaceuticals, Inc., a biotechnology company focused on the development of a first-of-its-... read more »

Astellas Provides Update on ASPIRO Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy
Astellas Pharma Inc announced that it has voluntarily paused screening and dosing of additional ... read more »

New FDA Drug Safety Communication on tofacitinib (Xeljanz, Xeljanz XR), baricitinib (Olumiant), and upadacitinib (Rinvoq)
FDA Requires Warnings About Increased Risk of Serious Heart-Related Events, Cancer, Blood Clots, and... read more »

Recall of Lidocaine HCl Topical Solution 4% by Teligent Pharma
Teligent is recalling one lot of Lidocaine HCl Topical Solution 4%, 50 mL (Lot # 14218, Exp. 09/2022... read more »

	Infographic

Top 5 Tips for Easier Bacterial Endotoxin Testing (BET)
BET is an essential step of pharmaceutical manufacturing for injectable drugs and implantable medical devices. Testing for endotoxins prevents fever ... read more »

	Featured Articles

Advancing to Recombinant Heparin Heparin is a potent anticoagulant that has been used clinically to manage blood clotting since 1935. Hundreds of thousands of doses are administered ... read more »

QC Corner: Recent Updates to Guidances Help Standardize Extractables and Leachables Testing Risk assessment for extractables and leachables (E&L) contained in polymeric manufacturing components is an important step to evaluate patient safety.... read more »

	Featured Video

On-Demand Webinar: Development and Validation of a Platform Assay Method Using Variable Pathlength Technology for Oligonucleotide Drug Products
This webinar will share Ionis’ experience with developing and validating a platform SoloVPE® in-process assay method for GMP manufacturing of ... watch »

On-Demand Webinar: Clarifying Pharmacopeial Requirements for Pharma Waters and Process Analytics
In this webinar you’ll learn answers to common questions to distinguish actual pharmacopeial requirements for pharmaceutical waters vs what has become... watch »

	Featured Products

eTOC series On-Line TOC Analyzer
read more »

	Featured Whitepaper

eBook: Implementing Microbial Analysis Technologies for World-Class Production
This eBook covers microbial testing, analysis, and monitoring technologies and strategies to ensure world-class pharmaceutical production. Article cover topics such as data integrity issues, ... read more »

	Events

9th Annual Immuno-Oncology Summit
Westin Copley Place, Boston, MA & Online – 10/04/2021
Over the past 9 years, CHI's Immuno-Oncology Summit has become the leading annual meeting focusing on the latest applied research, providing ... event details »

SMi’s Aseptic Processing Conference
London, UK – 09/20/2021
The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic ... event details »

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