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May 24, 2022

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Evolving Requirements for E&L Testing for Pharmaceutical Packaging

Regulators have over the last few years increased the requirements for extractables and leachables testing for pharmaceutical packaging. Many people in the pharmaceutical industry have been unsure about the current position of and requirements from regulatory agencies. It is crucial to understand what regulators really want and to design and carry out E&L studies in accordance with the regulatory expectations. Analytical testing labs need to be at the forefront, knowing what is expected from regulatory agencies and having the expertise to fulfill the most up-to-date testing requirements. Learn more.

	Industry News

Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years
Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable ... read more »

Innoviva to Acquire Entasis Therapeutics
Innoviva, Inc. and Entasis Therapeutics Holdings Inc. announced the companies have entered into a ... read more »

FDA Accepts for Review Biohaven's NDA Filing of Intranasal Zavegepant for the Acute Treatment of Migraine
Biohaven Pharmaceutical Holding Company Ltd. announced that the FDA has filed and accepted for ... read more »

Novartis Cosentyx® Receives Positive CHMP Opinion for Expanded Use in Childhood Arthritic Conditions
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European ... 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

Next-Generation Microscopy
Download this Infographic Now!
When evaluating advanced microscopes, it’s important to review the features, benefits, and options offered. read more »

	Featured Articles

Maximizing the Return on Investment of Water Quality Analyzers Water quality monitoring is a cornerstone of pharmaceutical production. Whether used as a raw material or for processing, formulation, reagents, ... read more »

Use of Statistical Models to Uncover Fraud, Shorten Timelines and Improve Patient Safety Unsupervised statistical monitoring could have uncovered fraud at a clinical trial site around a year earlier than traditional methods were able to do... read more »

	Featured Video

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

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 »

	Featured Whitepaper

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 »

eBook: Glass Related Recalls in Pharma
Typically, drug recalls fall into two categories: recalls issued for the cracking or breaking of glass vials and recalls issued for the presence of particulates being detected in the drug solution. read more »

	Events

ASMS Conference
Minneapolis, Minnesota – 06/05/2022
The 70th ASMS Conference on Mass Spectrometry and Allied Topics (ASMS 2022) will take place 5-9 June 2022 in Minneapolis, MN, USA. The annual ... event details »

World Pharma Week 2022
Online – 06/15/2022
Pharma R&D Week brings together thought leaders in biopharma R&D to discuss disruptive technologies and novel platforms, as well as strategies to cut ... event details »

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