American Pharmaceutical News In Review

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March 16, 2021

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[Webinar] Reactive-to-Proactive Process Monitoring in Pharmaceutical Waters

The importance of true real time methods for not only TOC, but also conductivity and bioburden vs a "trap and read" method, eliminates delayed results and water waste. It can also reduce overall cost and effort but ensures control of the water system and higher quality output. Using continuous trending of water system data for TOC, conductivity and bioburden measurements allows for focus on preventing bioburden growth and biofilm formation – which ultimately provides quick risk assessment to prevent undetected issues and avoid production shutdowns

	Industry News

Avacta’s Rapid Antigen Test Confirmed to Detect SARS-CoV-2 New Variants
Avacta has announced the AffiDX SARS-CoV-2 rapid antigen lateral flow test detects the dominant new ... read more »

Immutep Secures Second Patent Grant for Eftilagimod Alpha, A Pd-1 Pathway Inhibitor Combination
Immutep has announced the grant of patent number 10,940,181 entitled “Combined Preparations for the ... read more »

Adicet Bio Initiates ADI-001 Trial for B Cell Non-Hodgkin's Lymphoma
Adicet has initiated its First-in-Human Phase I clinical trial evaluating ADI-001 for the treatment ... read more »

Ortho's New COVID-19 Total, IgG Antibody Tests Receive CE Mark
Ortho Clinical Diagnostics announced that its new VITROS Anti-SARS-CoV-2 Total 2 Antibody assay and ... read more »

SciSparc to Commence Pre-Clinical Study Using CBD-Based Treatment for Epilepsy
SciSparc and The Sheba Fund for Health Services and Research will perform a study of non-... read more »

4D Molecular Doses First Patient in 4D-310 Trial for Fabry Disease
4D Molecular Therapeutics announced the first patient has been dosed in the Phase 1/2 clinical trial... 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 »

PyroSmart NextGen™ : Sustainable LAL Recombinant Cascade Reagent (rCR)
PyroSmart NextGen™ is the first and only recombinant reagent for kinetic chromogenic assays. Shown ... read more »

	Infographic

Measuring Total Organic Carbon (TOC) Continuously in Real-Time
Total Organic Carbon (TOC) control is essential in the production of high purity pharmaceutical water. Whether you are upgrading your current system ... read more »

	Featured Articles

Recent Advances to Help Cope with the Complexity of MS-Based Glycan Analysis In a post-translational modification reaction called glycosylation, living organisms attach carbohydrate residues known as glycans to their proteins. ... read more »

In-Situ Disinfectant Validation Case Study One of the key quality attributes for evaluating effectiveness of the cleaning and disinfection program is the in-situ validation. The requirement can... read more »

	Featured Video

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 »

On-Demand Webinar: Crush Particle Analysis Problems with Hound
In this webinar you'll learn approaches to address particle characterization needs across different material types and in different industries, how ... watch »

	Featured Products

CEOLUS UF Grade Microcrystalline Cellulose
read more »

Pyros Kinetix® Flex Incubating Kinetic Tube Reader
read more »

	Featured Whitepaper

Microbiology and More - Unleashing the Power of the MODA-EM Solution
Challenge: Capturing QC data electronically in a single system When setting up their facility in Tokyo, Japan, NCLi wanted to maximize the efficiency of their quality control (QC) laboratories by ... read more »

White paper: Making the Switch to In-House Mycoplasma Testing
Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines state that recombinant bulk harvest must be tested ... read more »

	Events

Performance Enhancement Strategies for Low Solubility APIs
Online – 03/18/2021
Close to 90% of drugs coming out of the drug discovery pipeline, have solubility limitations translating into poor bioavailability, which may ... event details »

Parallel Trade 2021
Virtual – 03/22/2021
SMi present’s its 15th annual Parallel Trade virtual conference, taking place virtually on the 22nd and the 23rd March 2021. As the only parallel ... event details »

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