American Pharmaceutical News In Review

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August 17, 2021

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Watch Webinar: Regulatory Compliance and Data Integrity for Microbial Testing Systems

Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from assays to data integrity, be qualified and validated to meet regulatory guidance in a CGMP environment. Therefore, when choosing a microbial testing solution, it’s important to have a clear path toward regulatory compliance from the start in order to avoid any costly complications down the road.

	Industry News

Moderna Announces Supply Agreement with Canada for Expanded Supply of Moderna’s COVID-19 Vaccine in 2022, in 2023 and in 2024
Moderna Inc., a biotechnology company pioneering mRNA therapeutics and vaccines, announced a revised... read more »

FDA Grants Emergency Use Authorization for Two Next-Generation COVID-19 Assays from Thermo Fisher Scientific
Thermo Fisher Scientific, the world leader in serving science, today announced that the U.S. Food ... read more »

DFE Pharma demonstrates Impact of Powder Properties on the Rheological Behavior of Excipients
With the recent publication of a new study demonstrating the impact of powder properties on the ... read more »

FDA approves Lyumjev® 100 units/mL for Insulin Pumps
The U.S. FDA has approved an expanded label for Eli Lilly and Company's (NYSE: LLY) rapid-acting ... read more »

	Infographic

6 Reasons to Switch to Automated Titration
If you still perform titrations the old-fashioned way (by hand), you are not alone. Learn how automation can improve not just sample throughput, but... read more »

	Featured Articles

How to Investigate Temperature and Humidity Excursions of Stability Chambers The purpose of a Stability Program is to support the expiration dating of pharmaceutical products, medical devices, and biologics and recommend ... read more »

Vaccines and Therapeutics for COVID-19 – How Can Understanding SARS-CoV-2 Glycosylation Lead to Pharmaceutical Advances? The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 160 million people worldwide. ... read more »

	Featured Video

On-Demand Webinar: A Straightforward Path Toward Regulatory Compliance and Data Integrity with Your Microbial Testing Systems
On-Demand Webinar: A Straightforward Path Toward Regulatory Compliance and Data Integrity with Your Microbial Testing Systems 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

AccuSizer SPOS Systems
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	Featured Whitepaper

eBook: BET Automation Simplified: How to achieve simple, automated endotoxin testing
To succeed and thrive in today’s pharmaceutical QC environment, it is critical to increase efficiency while maintaining compliance. The need to quickly and accurately test samples, review data, and ... read more »

	Events

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 »

Ophthalmic Drugs Conference
London, UK – 11/22/2021
The global ophthalmic drug market is forecast to surpass $60 billion USD by 2025 with increasing focus from the industry on alternative delivery ... event details »

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