American Pharmaceutical News In Review

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July 21, 2021

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Primary & Secondary Packaging Materials as potential source of Nitrosamines: impact on E&L study design

Recently there have been several drug product recalls due to the unexpected presence of N-Nitrosamines. While in most of those cases, N-Nitrosamine formation occurred at the level of the drug substance synthesis and stability, it is well known and documented that some materials, used in primary packaging can also be a source for N-Nitrosamine contamination

	Industry News

Novartis Pledges 10-Year Commitment with Morehouse School of Medicine, 26 Historically Black Colleges, Universities, Medical Schools
Novartis and the Novartis US Foundation announced a 10-year collaboration with Coursera, the ... read more »

SP’s Fill-Finish System Chosen by NIB RT for Advanced Training in Biopharmaceutical Production
SP Scientific Products (SP) announces a collaboration with the National Institute for Bioprocessing ... read more »

ADMA Biologics Completes FDA Manufacturing Facility Inspection
ADMA Biologics Inc. announced the US FDA completed its Pre-Approval Inspection (“PAI”) of the Boca ... read more »

DFE Pharma Expands Co-Processed Portfolio
DFE Pharma, a global leader in pharmaceutical excipient solutions, has a new addition to its ... read more »

	Infographic

5 Tips to Help Choose the Right TOC Sensor
Fast, continuous measurement of Total Organic Carbon (TOC) with an on-line analyzer allows real-time water release and ensures rapid detection of even... read more »

	Featured Articles

An Interview With Jim Huang, PhD - CEO - Ascendia Pharmaceuticals Ascendia Pharmaceuticals is a specialty pharmaceutical CDMO that provides custom sterile- and non-sterile-enabling formulations, along with analytical... read more »

A Model for Aseptic Operations Governance (Structure, Competencies, Governance and Attitude) Manufacturing sterile parenteral products with aseptic technique has become more complex because of multiple technical, scientific and compliance ... 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: How Vibrational Spectroscopy Helps to Accelerate New Drug Development and to Troubleshoot Drug Production
Webinar: How Vibrational Spectroscopy Helps to Accelerate New Drug Development and to Troubleshoot Drug Production watch »

	Featured Products

eTOC series On-Line TOC Analyzer
read more »

	Featured Whitepaper

eBook: Rapid and Continuous TOC Monitoring and Measurement
This eBook offers an in-depth look into the features and benefits of the latest TOC instruments designed to meet water requirements and regulations. Rapid and continuous TOC measurement is fast ... read more »

	Events

Wearable Injectors and Connected Devices Conference 2021
London, UK – 10/18/2021
SMi’s 2nd annual Wearable Injectors and Connected Devices Conference will explore real world case studies of on-body device design and development for... event details »

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 »

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