American Pharmaceutical News In Review

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June 07, 2022

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Packaging Materials as Potential Sources of N-Nitrosamines

There have been a number of drug-product recalls due to the unexpected presence of N-Nitrosamines. It is well known and documented that some materials used in primary packaging can be a source of N-Nitrosamine, which can lead to contamination of the packaged drug product. Examples are older-grade elastomers and nitrocellulose-laminated blister foils. The unanswered question is this: Do we know everything about the materials of construction of a container closure system and their ability to generate N-Nitrosamines? Learn more.

	Industry News

Shionogi Announces Strategic Re-Organization of U.S. Executive Leadership
Shionogi Inc., the United States subsidiary of Shionogi & Co., Ltd. based in New Jersey, has ... read more »

Astellas and GO Therapeutics to Develop Novel Antibodies for Immuno-Oncology
Astellas Pharma Inc. and GO Therapeutics, Inc. announced that Xyphos Biosciences, Inc., (a wholly ... read more »

Sana Biotechnology to Relocate Manufacturing to Bothell, WA Along with Key Executive Hires in Manufacturing and Regulatory
Sana Biotechnology announced that the company has entered into a lease agreement to develop an ... read more »

Immatics and Bristol Myers Squibb Expand Strategic Alliance to Develop Gamma Delta Allogeneic Cell Therapy Programs
Immatics N.V., a clinical-stage biopharmaceutical company active in the discovery and development of... read more »

	QC Corner

QC Corner: Environmental Monitoring as a Component of a Contamination Control Strategy
Watch Now! In this webinar, Mark Hallworth discusses environmental monitoring as a component of a ... read more »

	Infographic

Best Practices when considering an ATP Bioluminescence technology for Rapid SterilityTesting in accordance with Draft Chapter USP

This infographic provides seven best practices when considering an ATP bioluminescence technology for rapid sterility testing in accordance with draft... read more »

	Featured Articles

Using Slope Spectroscopy® to Streamline Development for AAV Titer Determination Processes Today, one of the primary challenges in the production of consistent quality of recombinant adeno-associated virus (rAAV) remains the fact that ... read more »

Middle-Up Strategies for Monoclonal Antibodies Thorough characterization of protein therapeutics is essential to ensure that drugs developed and manufactured meet all safety, efficacy, and quality ... read more »

	Featured Video

On-Demand Webinar: Modeling Inflammatory Immune Cell Recruitment and Response with the Colon Intestine-Chip
Join this webinar to learn how you can use the Colon Intestine-Chip to develop more effective, targeted therapeutic strategies for IBD across an ... watch »

On-Demand Webinar: The Data Quality Journey – Focus on Environmental Monitoring Systems
Live Webinar: The Data Quality Journey – Focus on Environmental Monitoring Systems watch »

	Featured Products

Discovery DSC 2500
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EZ-Accu Shot™ Growth Promotion Test
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4Cell® NutriVero™ Flex 10 Medium
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	Featured Whitepaper

Whitepaper: Avicel® RC/CL: An Outstanding Excipient for Formulation Stability in Suspensions
Patient noncompliance contributes to 50% of all treatment failures and adds billions of dollars to healthcare costs worldwide.1 To address this gap, pharmaceutical manufacturers are increasingly ... read more »

eBook: Guidance for Cell and Gene Therapy Manufacturing - Meeting GMP and Regulatory Challenges
As biopharmaceutical manufacturers embrace new technologies, mycoplasma testing continues to present challenges at various stages in the production process for cell therapy products. Risk assessment ... read more »

	Events

IFPAC 2022
North Bethesda, MD – 06/12/2022
IFPAC brings together experienced professionals and the next generation of leaders to share in discussions, give input and get ideas for the future ... event details »

Prefilled Syringes West Coast
San Diego, CA, USA – 06/13/2022
SMi is delighted to announce the 6th annual Pre-Filled Syringes West Coast conference, to be held in San Diego. As part of SMi’s leading series of ... event details »

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