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October 26, 2023

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Container Closure Integrity Testing: New Requirements

Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical for the sterility of drug products. New USP requirements contained in chapters <661.1>, <661.2>, and <382> are to be made official by the end of 2025 and will result in changes to CCIT.

	Industry News

PTC Therapeutics Announces Evrysdi Agreement with Royalty Pharma for Up To $1.5B
PTC Therapeutics, Inc. announced an agreement with Royalty Pharma plc. to monetize up to $1.5 ... read more »

Valneva Submits Chikungunya Vaccine Marketing Application to EMA and Receives CHMP Accelerated Assessment
Valneva SE announced the submission of a marketing application with the European Medicines Agency (... read more »

Pfizer and BioNTech Announce Data for mRNA-based Combo Vaccine Program Against Influenza and COVID-19
Pfizer Inc. and BioNTech SE announced positive topline results from a Phase 1/2 study (NCT05596734) ... read more »

BMS Announces FDA Breakthrough Therapy Designation for Pulmonary Fibrosis Treatment
Bristol Myers Squibb announced that the FDA granted Breakthrough Therapy Designation for BMS-986278,... read more »

	QC Corner

Increase Control and Productivity of CDS for Pharmaceutical Analysis/QC, Data Management, and Compliance
In this webinar, hear from Laércio Fernandes from Thermo Fisher Scientific as he discusses how to ... read more »

	Infographic

API Reference Standard Selection
This infographic outlines essential information for drug developers when choosing a reference material to meet ISO 17034. read more »

	Featured Articles

		Challenges of Analytical Validation for ATMPs Quality Control of medicinal products is a fundamental aspect for assuring the quality, efficacy and safety of the product. Testing of the product at ... read more »

		R Code to Estimate Probability of Passing USP Dissolution Test Dissolution testing is required by the United State Pharmacopeia (USP) to ensure that the drug products meet the established standards of strength, ... read more »

	Featured Video

On-Demand Webinar: Optimizing Bioprocess Harvest: Unlocking Efficiency with Inline Particle Analysis
In this webinar, hear from Tyler Gable, Ph.D. as he evaluates acidic precipitation of nucleic acids in cell culture broth to improve filtration and ... watch »

On-Demand Webinar: Understanding Molecular and Macroscopic Powder Mechanics for Smart Pharmaceutical Material Reengineering: Curious Case of Metformin HCl
Metformin HCl is a highly prescribed anti-diabetic drug. This drug poses various challenges in tablet manufacturing in addition to a high dose. In ... watch »

	Featured Products

VACUUBRAND® PC 3001 Vario® Select Vacuum Pump
BrandTech® Scientific The VACUUBRAND PC 3001 VARIO select is an ideal choice to support various steps in the extraction ... learn more »

Aclar® Crystal-clear Barrier Films
Honeywell Aclar® barrier films: committed to a safer and more sustainable future Aclar® is a clear, high-... learn more »

Polyplasdone™ Plus Multifunctional Disintegrant
Ashland Inc. Polyplasdone™ Plus multifunctional disintegrant is a direct compression superdisintegrant containing... learn more »

	Featured Whitepaper

Whitepaper: Extractables and Leachables Testing
Our scientists have a thorough working knowledge of plastics, rubber, and elastomeric materials, those compounds most frequently used in today’s pharmaceutical manufacturing, packaging, and delivery ... read more »

Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
This article explores various viral vector testing methods in gene therapy, such as identity testing, quality testing, stability testing, and more. Download now to learn more. read more »

	More Products

Central Chiller Systems for Manufacturing Learn More
ADAPTA 200 Capsule Filler Learn More
2465 Electrochemical Detector Learn More

	Directory Categories

Pharmaceutical Bioreactors and Fermentors Search More

Pharmaceutical Capsule Filling Machine Search More

Pharmaceutical Excipients Search More

	Events

Global Bioprocessing Summit
Berlin, Germany – 11/16/2023
The industry, professionals, and scientists are actively seeking methods to delineate more precise guidelines and anticipated requirements for ... event details »

Eastern Analytical Symposium 2023
Plainsboro, NJ – 11/13/2023
Each year the Eastern Analytical Symposium honors Analytical Chemists who have distinguished career achievements. event details »

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