American Pharmaceutical News In Review

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February 23, 2021

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Register Now: Scalable In-line Concentration Measurement for Biologic Process Development and GMP Manufacturing clone
In this webinar we will demonstrate how the FlowVPE Slope Spectroscopy System, when directly integrated in one or more locations of a process stream, has helped reveal process characteristics that until now have been hidden due to the limitations of the most commonly used online fixed pathlength UV-Vis solutions.

	Industry News

FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
The FDA has issued guidances for medical product developers, specifically covering vaccines, ... read more »

AnteoTech’s AnteoBind Technology Supports COVID-19 Home Test
AnteoTech’s long-term customer Ellume has secured a $231.8 million agreement with the U.S. ... read more »

J&J Announces Single-Shot Janssen COVID-19 Vaccine Candidate Submission to WHO
J&J announced Janssen-Cilag International has submitted for EUL to the WHO for the investigational ... read more »

Blackfynn Builds Therapeutic Pipeline with Option to a Phase 3-Ready Drug for Parkinson's
Blackfynn has entered into an agreement with an undisclosed partner to acquire rights to a Phase 3-... read more »

Cascade Chemistry Initiates Expansion of cGMP Manufacturing Capacity
Cascade Chemistry announced initiation of construction of new facilities designed to increase the ... read more »

FDA Approves Libtayo
Regeneron announced the FDA has approved the PD-1 inhibitor Libtayo for the first-line treatment of ... 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 »

Filing a Multistage Continuous Process for API
In recent decades, the pharmaceutical industry has witnessed a revolution in the regulatory ... read more »

	Featured Announcements

Webinar: High Potency API: Strategies for HPAPI Containment to Enable Rapid Development and Production
Do you have questions about the latest in CDMO trends, best practices, and technologies in the pharmaceutical and biotechnology industry? This on-demand webinar is part of AMRI’s Casual Nexus – an informal, discussion-based 30-minute webinar series ... 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

Economics of Perfusion Culture Media and Upstream Processing Cell culture media and its development have been one of the most vital parameters influencing the performance and facilitating adoption of perfusion ... read more »

An Interview With... Vaibhav Kshirsagar, Technical Product Manager, IMA Life North America Operating through six production sites, IMA Life (Aseptic Processing & Freeze Drying Solutions) is one of the three pharmaceutical divisions of the ... read more »

	Featured Video

On-Demand Webinar: Solid Form Analysis – In-depth Understanding of API’s Behavior
In this webinar you’ll learn how to evaluate stability of a formulation early in the drug product development process, what impact can distribution of... watch »

On-Demand Webinar: Sustainability In Bacterial Endotoxin Testing – A Holistic Approach to Conservation and Recombinant Technology
In this webinar you’ll learn about the current conservation/sustainability status of the horseshoe crab population in the US, new developments in ... watch »

	Featured Products

CEOLUS UF Grade Microcrystalline Cellulose
read more »

BD Select BD Cell Hybridoma MAb Medium - Quantum Yield
read more »

	Featured Whitepaper

Tips for Choosing a Reliable Temperature Control System in the Pharmaceutical Industry
When considering a temperature control system for medical processing, precision and accuracy are key. Mokon’s advanced solutions are relied on by critical medical, pharmaceutical and biotechnology ... read more »

Hard Choices: Decontamination of plastic surfaces with UVC light
The germicidal effect of ultraviolet-C (UVC) light has proven effective as a no-touch, fast, and residue-free solution against microorganisms and biomolecules. UVC treatment conditions are highly ... read more »

	Events

SMi’s 2nd Annual AI in Drug Discovery
Online – 03/15/2021
Chaired by: Darren Green, Director of Molecular Design & Senior Fellow, GSK Sponsored by: Cas Group & Dassault Systèmes Exploring the latest ... event details »

Excipient World 2021
National Harbor, MD – 09/27/2021
Excipient World is the leading education, networking and sourcing resource for the $6+ billion and growing global excipient market. It’s the ONLY U.S.... event details »

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