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April 19, 2021

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Where N-Nitrosamine assessments for Drug Products meet Extractable / Leachable Qualifications for Pharmaceutical Primary Packaging

Recently there have been a number of 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 of the packaged drug product (e.g. older grade elastomers and nitrocellulose laminated blister foils).

	Industry News

AstraZeneca Receives US Clearance of Proposed Acquisition of Alexion
AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, Inc has achieved an important step ... read more »

Sartorius Expands in the UK By Relocating to a New Facility for Downstream Processing Equipment
New 58,000-square-foot facility will simplify and accelerate the production of downstream processing... read more »

Evobrutinib is the First and Only BTK Inhibitor to Demonstrate Reduction of a Key Biomarker of Neuronal Damage and Inflammation in Patients with MS
Data presented at AAN shows investigational evobrutinib significantly reduced blood neurofilament ... read more »

	QC Corner

The Analytical Power of Raman Imaging for Life Sciences & Pharmaceutics
Confocal Raman imaging microscopy is a non-destructive chemical characterization method, which can ... read more »

On-Demand Webinar: Quality Control in the Next Normal
On-Demand Webinar: Quality Control in the Next Normal read more »

	Featured Announcements

Infographic: Engineering Monoclonal Antibodies for COVID-19
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Today, mAbs make up more than half of the total biopharmaceutical market. That’s why it makes sense that, when the world was thrust into an unprecedented pandemic last year, scientists quickly turned their attention to monoclonal antibodies as a ... read more »

	Infographic

Levels of Disinfectant Claims When Marketing a New Disinfectant
Whether you have an existing disinfectant or are looking to launch a new product into the market, the EPA requires several testing criteria to be met ... read more »

	Featured Video

On-Demand Webinar: Validation of BET Platforms and Product Samples: What is Required and What are Some of the Common Challenges?
What has your experience with endotoxin systems and product validation been like? In this webinar, we will look at what steps are needed for a new ... watch »

On-Demand Webinar: Development and Validation of a Robust Commercial Solution for Measuring Residual Kanamycin-Resistant Plasmid DNA
In this webinar you’ll learn: overview of current regulatory requirements for residual DNA clearance for biological products including residual ... watch »

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