American Pharmaceutical News In Review

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January 20, 2021

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Webinar: Key Considerations for Implementing Rapid Microbial Methods for Mycoplasma Detection

In this webinar you’ll learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.

	Industry News

ARUP Sequencing Specimens Able to Detect the UK Variant of COVID-19
ARUP Laboratories announced it is sequencing variants of SARS-CoV-2 in specimens positive for COVID-... read more »

Biomerica’s 15-Minute COVID-19 Antigen Rapid Test Receives CE Mark
Biomerica has received CE Mark for its new COVID-19 Rapid Antigen Test for detection of COVID-19 ... read more »

Biohaven Provides Update on Phase 2/3 Trial, Alzheimer's Program
Biohaven has completed a focused analysis of the topline co-primary and key secondary data from its ... read more »

Creative Medical Technology Announces Positive Data Using ImmCelz to Treat Type 1 Diabetes
Creative Medical Technology Holdings announced positive data and filing of a patent application ... read more »

Travere Announces Orphan Drug Designation for IgA Nephropathy Treatment
Travere Therapeutics announced the FDA has granted Orphan Drug Designation to sparsentan for the ... read more »

Harpoon Therapeutics Granted Orphan Drug Designation for Multiple Myeloma Treatment
Harpoon Therapeutics announced the FDA has granted Orphan Drug Designation for HPN217 for the ... read more »

	QC Corner

The Role of Chemical Development and Drug Substance Manufacturing in Early Integrated CMC Development at Emerging and Virtual Pharma
Integrated chemistry, manufacturing and controls (CMC) development views the entire effort to ... read more »

The Business Case for Process Analytical Technology (PAT) – A Starting Point
The presentation of a new Process Analytical Technology (PAT) application to a pharmaceutical ... read more »

	Featured Articles

An Interview with... Oliver Stauffer, CEO, PTI - Packaging Technologies & Inspection PTI is a solutions provider for high-risk container closure integrity applications. read more »

Nonlinear Optical Spectroscopy Techniques for Pharmaceutical Analysis Ensuring the quality of pharmaceutical products is paramount for bringing them to market. This calls for analytical methods with high accuracy, ... read more »

	Featured Video

On-Demand Roundtable: A Quality Perspective Roundtable Discussion on the Successes and Challenges of Making Changes to Pharma Workflow
In this roundtable you’ll learn about challenges faced by pharmaceutical quality teams in their material analysis workflows, and real-world solutions,... watch »

On-Demand Webinar: Development and Validation of a Duplex qPCR assay for the Detection of Residual Sf9 Host Cell DNA and Baculovirus DNA
In this webinar, you will learn more about current regulatory requirements for residual host DNA clearance for biological products and what that means... watch »

	Featured Products

Crodasol HS HP
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Pegasus 4D GCxGC-TOFMS
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	Featured Whitepaper

Recognizing the Potential Impact of Agitation Directionality On Oxygen Mass Transfer Through a kLa Evaluation Within the BIOne Single-Use Bioreactor
Defining a suitable agitation strategy is essential for the successful development of upstream mammalian bioprocesses. read more »

White Paper: Optimizing the Bio-Rad NGC Chromatography System for Cryo-EM Applications for High-Resolution and Low-Volume SEC
Structural biology is the three-dimensional study of complex biological molecules, like proteins, to determine their structures at atomic resolution. read more »

	Events

Commercializing Continuous Processing in Pharma 2021
Virtual – 03/23/2021
The 5th Commercializing Continuous Processing in Pharma 2021 will reunite the growing CCP community to discuss how to accelerate adoption of ... event details »

CPhI North America
Philadelphia, PA – 04/20/2021
Over the last three years, CPhI North America has brought together more than 15,000 industry professionals across the entire pharmaceutical supply ... event details »

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