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September 20, 2022

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N-Nitrosamines in the Primary Packaging of Drug Products

Recent product recalls due to the presence of N-Nitrosamines remind us that it is critical to know everything we can about the components of the primary packaging of drug products. It is commonly known that secondary amines are a precursor to N-Nitrosamine formation and that these need to be taken into consideration. It is important to look at the formation of these amines on materials prominently used in the primary packaging of drug products. Learn more.

	Industry News

Mallinckrodt Appoints Lisa French as CCO
Mallinckrodt plc announced it has appointed Lisa French as Executive Vice President and Chief ... read more »

New Pancreatic Cancer Drug Receives Orphan Drug Designation by FDA
Antengene Corporation Limited announced that ATG-101, the company's in-house developed novel PD-L1/4... read more »

AbbVie Gets Positive CHMP Opinion for SKYRIZI® to Treat Adults with Moderate to Severe Crohn's
AbbVie announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for ... read more »

Merck Receives Positive CHMP Opinion for VAXNEUVANCE in Infants and Children
Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use ... read more »

	QC Corner

QC Corner: Regulatory Update: Rapid and Alternative Methods for ATMPs Webinar
In this on-demand webinar, Brice Chasey, Associate Director of Product Management at Charles River ... read more »

	Infographic

Pharmaceutical Water: A Brief Q&A on Water Quality Analysis and Compliance
Download this Q&A to learn more!
Download this Q&A for five of the most asked questions (and answers) from the USP’s website regarding water system usage, analysis and compliance. read more »

	Featured Articles

		Maintaining Data Integrity During the Migration to Real-Time Testing Implementing Real-Time Testing (RTT) or Real-Time Release Testing (RTRT) in pharmaceutical manufacturing is becoming a more widespread goal to improve... read more »

		An Interview with Veronika Wills - Manager, Technical Services Associates of Cape Cod, Inc. The methods that are currently defined in the harmonized Bacterial Endotoxins Testing (BET) chapters are all based on the use of animal derived ... read more »

	Featured Video

On-Demand Webinar: The Recombinant Factor C Assay, An Equivalent Alternative to LAL Assays
In this webinar, you’ll learn about: the history of the PyroGene® Recombinant Factor C Assay; the need for an alternative method; Recombinant Factor C... watch »

On-Demand Webinar: High-Throughput and Wide-Range Protein Concentration Determination of Monoclonal Antibodies
In this webinar you’ll learn how to counteract the increasing risk of missing deadlines due to slow one-at-a-time quantification on large numbers of ... watch »

	Featured Products

BRAND® Transferpette® S PipetteBRANDTECH® Scientific Brought to you by BrandTech® Scientific, BRAND® Transferpette® S Pipette is the performance standard... learn more »

Custom Environmental Isolate ControlsMicrobiologics Microbiologics offers Custom Environmental Isolate Controls to streamline and strengthen ... learn more »

Nexera XS inert UHPLCShimadzu Scientific Instruments Providing the same expandability and superior performance advantages of the Nexera Series of Modular... learn more »

	Featured Whitepaper

Case study: Bridging Data Management Gaps in Pharmaceutical Development
In 2019, a top US biopharmaceutical company began working to improve the synthetic route of an API. In addition to route development, the process development team wanted to streamline chemical and ... read more »

eBook: Digital Sensor Technology for Real-time Diagnostics in Bioprocessing
This eBook covers a wide range of topics detailing the technologies and benefits of using digital sensors for bioprocessing applications. Specific topics covered include: reasons to switch to ISM ... read more »

	More Products

PATROL UPLC Laboratory Analyzer System Learn More
PD22I Tabletop Aseptic and Peristaltic Filler Learn More
Affinity Isothermal Titration Calorimeter Learn More

	Directory Categories

Pharmaceutical Manufacturing Equipment Search More

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	Events

Webinar: Analysis of Nitrosamines in Drugs According to Regulatory Requirements
Online – 10/06/2022
A live round-table discussion hosted by MilliporeSigma on October 6th, 2022 in which a panel of experts will discuss some of the current ... event details »

CPHI/ ICSE/ P-MEC/ bioLIVE/ Hi Korea 2022
COEX, Korea – 09/28/2022
From leading domestic and international companies to big pharma startups. A variety of companies with innovative technologies in the field of ... event details »

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