American Pharmaceutical News In Review

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December 07, 2020

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Microbiological Control in a Pharmaceutical Manufacturing Environment

We address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data. We will review microbiological trending and how it can assist in understanding what is significant in each particular situation. We discuss how the analysis of this trended data enables a company to establish alert and action levels as well as methods for determining these levels.

	Industry News

Baricitinib Receives EUA for Hospitalized Patients with COVID-19
Eli Lilly and Incyte announced the FDA issued an EUA for the distribution and use of baricitinib in ... read more »

Sosei Heptares' COVID-19 Program Identifies Potent Broad Spectrum Anti-Viral Small Molecules
Sosei announces a progress update for its R&D program focused on the design and development of novel... read more »

Mount Sinai, Boehringer Ingelheim to Evaluate Nintedanib for Fibrosing ILD Following COVID-19
The Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim announced the first patient has... read more »

FlowMetric Launches COVID-19 Antibody Test
FlowMetric Life Sciences has created and brought to market a COVID-19 antibody test. read more »

SIFI Completes Enrollment for Acanthamoeba Keratitis Study
SIFI has achieved the full enrollment of 135 patients with Acanthamoeba keratitis in its pivotal ... read more »

Novartis Set to Achieve 100% Renewable Electricity in European Operations
Novartis announced the signature of five VPPAs, which are expected to collectively add more than 275... read more »

	QC Corner

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

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 »

	Featured Announcements

Microbial Identification for All: Exploring the MicroSEQ ID Microbial Identification System
Webinar
Join us for a webinar on December 3rd regarding the MicroSEQ ID System. This ID system is based on sequence analysis of ribosomal genes in bacteria and fungi. The MicroSEQ ID method is a well-established genotypic system that has been adopted by 23 ... read more »

	Infographic

Six Reasons to Make the Shift to Rapid Cycling Chromatography
The biopharmaceutical industry is looking for ways to cut costs in both the development of new biologics and bulk manufacture. In addition, facilities... read more »

	Featured Articles

Launch and Scale-Up of Multiproduct/Multiplatform Cell Therapy Manufacturing Facilities Cell therapies are living drug products that continue to provide hope and promise to patients around the world. They are transformative biological ... read more »

Why analyte binding to syringe filters must be studied during filter validation for QC testing Many pharmaceutical QC tests such as dissolution testing, content uniformity, assay, and blend uniformity require sample filtration prior to HPLC or ... read more »

	Featured Video

On-Demand Webinar: Platform Purification Approaches for the Production of Complex Biologics
In this webinar we will discuss the attributes of Thermo Scientific POROS Ion Exchange and Hydrophobic Interaction chromatography resins, addressing ... watch »

Watch Video: Introducing the SKANFOG SPECTRA
Watch Video: Introducing the SKANFOG SPECTRA watch »

	Featured Products

MB-Rx Insitu Reaction Monitoring Analyzer
read more »

Diffucaps Customized Release Technology
read more »

	Featured Whitepaper

eBook: Lipid Technologies: Helping to Develop the Next Generation of Pharmaceuticals
The FDA recently issued guidance intended to curtail the use of medically important antibiotics in agricultural applications. read more »

eBook: TOC and Microbial Detection Monitoring
Proper and thorough monitoring of pharmaceutical water systems is imperative to deliver the highest quality products to patients. read more »

	Events

Particle Engineering of Biopharmaceuticals
Online – 12/09/2020
Biopharmaceuticals represent the most promising and fastest growing field in the pharmaceutical area. event details »

Pittcon 2021
Virtual – 03/08/2021
Pittcon is a dynamic, transnational exposition and comprehensive technical conference, a venue for presenting the latest advances in research and ... event details »

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