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June 15, 2023

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Annex 1 Environmental Monitoring Common Questions and Answers

The newly published Annex 1 comes into effect this August 2023. Particle Measuring Systems have been involved in discussions with industry and regulatory focused teams defining how best to address the new elements of environmental monitoring to meet these new requirements. Join environmental monitoring expert Mark Hallworth as he shares frequently received questions along with practical answers to help you meet your EM needs.

	Industry News

Astellas and Cullgen Collaborate to Advance Innovative Targeted Protein Degraders
Astellas Pharma and Cullgen announced a research collaboration and exclusive option agreement to ... read more »

The Harvard Drug Group Recalls Dronabinol and Ziprasidone Capsules Due to Label Mix-up
The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories is initiating a ... read more »

Sandoz Introduces Act4Biosimilars Plan to Accelerate Patient Access to Biosimilars
Sandoz announced the launch of a global roadmap to increase patient access to biologic medicines. ... read more »

Alvotech and Teva Secure U.S. License Date for AVT04, a Proposed Biosimilar to Stelara®
Alvotech and Teva Pharmaceuticals announced they have reached a settlement and license agreement ... read more »

	QC Corner

QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more »

	Infographic

Reducing Water Use in Pharmaceutical Manufacturing
This infographic summarizes why water use is so high in the pharmaceutical industry, gives a look at regulatory and corporate initiatives to lower ... read more »

	Featured Articles

		Moving Towards Genome Integrity Evaluation of Gene Therapy Viral Vectors Gene therapy is a rapidly developing field that holds promise for the treatment of a variety of genetic disorders. One of the most important ... read more »

		Application of USP General Chapter in the Development of a Procedure for Quantitative NMR NMR spectroscopy has an almost 100-year history since the first measurement of nuclear magnetic moments in the 1930s. It has historically been ... read more »

	Featured Video

Watch Video: Humidity Calibration and the Indigo Platform
In this video, hear from Kevin Walsh, Application Sales Engineer from Vaisala as he talks about the humidity calibration and the Indigo platform in ... watch »

Watch Video: New Age Industries® Single Use Systems for Biologics and Pharmaceuticals
In this video, hear from Ken Baker, CEO of New Age Industries® as he talks about Single Use Systems for Biologics and Pharmaceuticals. watch »

	Featured Products

Ambr® 250 High Throughput Multi-Parallel Bioreactor
Sartorius Stedim Biotech GmbH High throughput automated bioreactor system with 12 or 24 fully featured single-use 100 to 250 mL ... learn more »

Pyrosate Kit Rapid Endotoxin Detection
ACC The Pyrosate kit offers some unique advantages over standard LAL gel-glot testing methods. The assay... learn more »

Kilian KTP 590X Rotary Tablet Press
Romaco Group KTP 590X single-sided rotary press from Romaco Kilian for mono- and bi-layer mode The cool – fast – ... learn more »

	Featured Whitepaper

Whitepaper: Adopting the Monocyte Activation Test for Sustainable Pyrogen Testing
Adopting the Monocyte Activation Test (MAT) for rabbit-free pyrogen testing of pharmaceutical preparations is highly encouraged for meeting product safety demands. This White Paper draws on an ... read more »

Whitepaper: Are Nitrosamines a Concern for Biologic Manufacturers?
The discovery of nitrosamine genotoxins in several pharmaceuticals has led to monitoring and re-evaluation of manufacturing practices for those products considered at risk. This article provides an ... read more »

	More Products

8700 LDIR Chemical Imaging System Learn More
CE 4500 Fluorescence Detector Learn More
DataAnalyst Particle Counter Software Learn More

	Directory Categories

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	Events

AAPS 2023 PharmSci 360
Orlando, FL – 10/22/2023
AAPS brings together pharmaceutical scientists from around the world to share research and exchange ideas in order to improve global health. PharmSci ... event details »

CRS 2023 Annual Meeting
Las Vegas, Nevada, USA – 07/24/2023
The 2023 Annual Meeting & Expo reflects our focus on cutting-edge research and innovation across our strong discipline that will keep you up-to-date ... event details »

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