American Pharmaceutical News In Review

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July 31, 2023

Newsletter Sponsor

White Paper: Upstream Process Development with a kLa Criterion Within the BIOne Single-Use Bioreactor

The FDA's Quality by Design (QbD) directive emphasizes the importance of comprehensive bioprocess characterization and understanding in future bioprocess development. It is recommended that process development incorporates a central criterion that describes the extracellular environment, aligning with this philosophy. Accordingly, we conducted innovative HEK-293 batch process development within the BIOne SUB, employing a k_La central criterion to establish operational definitions for our volume-dependent parameters. Download this white paper to learn more about the results of this study.

	Industry News

FDA Takes Steps to Facilitate Innovation for Devices Intended to Treat Opioid Use Disorder
The FDA announced steps to help facilitate innovation in devices intended to treat opioid use ... read more »

Alexion, AstraZeneca Rare Disease, to Acquire Pfizer Portfolio of Preclinical Rare Disease Gene Therapies
Alexion, AstraZeneca Rare Disease, announced that it has entered a definitive purchase and license ... read more »

AstraZeneca Appoints New Executive VP Biopharmaceuticals R&D
AstraZeneca announced the appointment of Sharon Barr as Executive Vice President, Biopharmaceuticals... read more »

United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation
United Therapeutics Corporation announced that the United States Court of Appeals for the Federal ... read more »

	QC Corner

On-Demand Webinar: Ensure your Pipetting is QC Compliant
In this webinar, Joni Åke, Product Manager at Sartorius, and Axel Taube, Service Product Manager at ... read more »

	Infographic

Pharma Tech Compare: MMS vs Traditional IR
Download this infographic to read about four key benefits that distinguish MMS from traditional IR methods. read more »

	Featured Articles

		Building a Strong Data Foundation for Decentralized Clinical Trials with an FSP Model By bringing trials directly to patients, decentralized clinical trials (DCTs) offer a host of compelling benefits, including reduced patient burden, ... read more »

		Unlocking the Potential of Medical Imaging as Real-World Data The FDA’s definition of “real-world data” (RWD) includes “data derived from electronic health records, medical claims data, data from product or ... read more »

	Featured Video

On-Demand Webinar: Initiating Confidence in Your Organizations Data Governance
Live Webinar: Rapid Micro watch »

The Pharma Flash – Regulatory News and More in this Week’s Pharma Flash
Watch Video: FDA approves OTC oral contraceptive and Fast-Track STD treatment plus more news in this week’s Pharma Flash. watch »

	Featured Products

Klucel™ xtend Hydroxypropylcellulose (HPC) Controlled Release Matrix Former
Ashland Inc. Klucel™ xtend hydroxypropyl cellulose (HPC) is a controlled release matrix former, designed to ... learn more »

Aquarius™ Genesis Film Coating System
Ashland Inc. Aquarius™ Genesis film coating systems are designed for application at up to 35% solids, which can ... learn more »

BRAND® HandyStep® Touch Electronic Repeating Pipette
BRANDTECH® Scientific The BRAND® HandyStep® Touch and Touch S are the first electronic repeating pipettes with touchscreen... learn more »

	More Products

Abbemat 200 Economy Line Refractometer Learn More
ALPHA FTIR Routine Spectrometer Learn More
UniCond 2-electrode Conductivity Sensor Learn More

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	Events

AAPS PharmSci 360
Orlando, FL – 10/22/2023
PharmSci 360 delivers research from across the pharmaceutical continuum, from discovery to delivery, and all stages in between. Thousands of ... event details »

15th Annual Next Generation Dx Summit
Washington, D.C. – 08/21/2023
CHI's 15th Annual Next Generation Dx Summit will take place in-person at the Grand Hyatt Washington, D.C. on August 21-23, 2023. The Next Generation ... event details »

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