American Pharmaceutical News In Review

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October 08, 2021

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While automation and robotics exist to improve efficiency for cumbersome assays such as bacterial endotoxins testing (BET), most labs haven’t fully adopted these practices due to the complexities that often come with them. In this eBook, we explore what automation of endotoxin testing entails and how to implement simplified endotoxin testing in your organization.

	Industry News

FDA Announces Availability of Draft Guidance on Microbiological Quality Considerations in Non-sterile Drug Manufacturing
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for ... read more »

Sandoz Resolves Legacy Federal Government Civil Investigation in the U.S. Regarding Generic Drugs
Sandoz has entered a settlement agreement with the Civil Division of the U.S. Department of Justice ... read more »

Bayer Recalls Lotrimin and Tinactin Spray Products Due to Benzene Impurity
Bayer is voluntarily recalling all unexpired Lotrimin® AF and Tinactin® spray products with lot ... read more »

FDA Approves Brexucabtagene Autoleucel For Leukemia Treatment
The FDA has approved brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) for adult patients with... read more »

	Infographic

The Top 4 Considerations in Lyophilized Product Development
To eliminate the concern of parenteral pharmaceuticals becoming unstable over time, lyophilization, or freeze-drying, is used to remove the water from... read more »

	Featured Articles

Countering Misinformation Spread About the COVID-19 Pandemic Today it’s a free-for-all on social media, which has become the main source of information for people on the COVID-19 pandemic, and sometimes a major ... read more »

Quantifying AAV Viral Titer and Integrity with ddPCR As the COVID-19 pandemic and subsequent vaccine development showed us, viruses and their components can both cause disease and help prevent it. While ... read more »

	Featured Video

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 »

On-Demand Webinar: Validation of a Mycoplasma NAT Platform for Product Release in Cell Therapy
This webinar will provide a review of validation strategies and implementation for a rapid at-line mycoplasma test for cell therapy companies. watch »

	Featured Products

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	Featured Whitepaper

eBook: Primary Packaging for Optimized Fill & Finish
Without effective, well-thought-out primary packaging, the drugs made by the global pharmaceutical industry would not be as effective as they are. Defects on the glass surface are a major cause of ... read more »

	Events

Wearable Injectors and Connected Devices Conference 2021
London, United Kingdom & Online – 10/18/2021
Innovations in on-body devices and connectivity to aid drug delivery and patient experience The global wearable devices market size is expected to... event details »

Medical Wearables for Biosensors USA Conference 2021
Boston, MA – 10/25/2021
Exploring therapeutic applications of connected on-body devices The global wearable biosensors market is a rapidly expanding industry with ... event details »

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