American Pharmaceutical News In Review

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December 08, 2020

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Webinar: Choosing the Right Method for Characterizing Biologics

This webinar looks at biophysical methods like NMR, DSC, and MALS, explaining how they function as stand-alone methods, and will cover orthogonal methods to see how they can be leveraged to qualify, validate, and give confidence to the methodology. Learn to choose and apply the right methods at the right time to fully understand your biologic molecules.

	Industry News

Avacta Announces SARS-CoV-2 Rapid Antigen Test Update
Avacta Group has announced progress in the development of a highly scalable manufacturing process ... read more »

FDA Approves Zokinvy for Hutchinson-Gilford Progeria Syndrome
Eiger announced the FDA has approved Zokinvy for the treatment of Hutchinson-Gilford Progeria ... read more »

Imfinzi Approved in US for Less-Frequent, Fixed-Dose Use
Imfinzi has been approved in the US for an additional dosing option in the approved indications of ... read more »

RedHill Biopharma Initiates Study of RHB-204 for NTM Disease
RedHill Biopharma has initiated its Phase 3 study to evaluate the safety and efficacy of RHB-204 as ... read more »

FDA Approves Danyelza
The FDA approved Danyelza for use in combination with granulocyte-macrophage colony-stimulating ... read more »

Glycostem Initiates Trial to Evaluate oNKord for AML
Glycostem Therapeutics announced the opening of a phase I/IIa trial for its lead product oNKord for ... read more »

	QC Corner

QC Corner: Quality Control in Pharmaceutical Development
Bikash Chatterjee, Chief Operating and Science Officer at Pharmatech Associates discusses quality ... read more »

Impact of Container Closure on Drug Safety
Pharmaceutical product container closure systems (CCS) should be designed to ensure that a drug ... read more »

	Infographic

Science of Scale for Spray-Dried Intermediates
Effective technology scaling requires in-depth knowledge of problem statements, process parameters, tools, and equipment. Lonza scientists and ... read more »

	Featured Articles

Accelerating Trends in Bioprocessing COVID-19 Crisis Intensifies Need for Collaborative Solutions The trends affecting the biopharma industry that we’ve evaluated over the past decade have remained relatively stable. In this highly regulated ... read more »

Points to Consider When Designing an Environmental Monitoring Trending Program Environmental monitoring (EM) trending programs are an integral tool for use in making sound, scientifically justified cGMP decisions. Moreover, the ... read more »

	Featured Video

Watch Video: Dissolution is Beautiful from Sotax
Dissolution is Beautiful from Sotax watch »

On-Demand Webinar: In Vitro Test Methodologies for Characterizing Bioavailability Enhancing Formulations
This webinar discusses several in vitro methodologies used at Lonza for the characterization of bioavailability enhancing formulations as well as ... watch »

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	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 »

The Process of Pharmaceutical Elastomer Selection for Injectable Biologics
Even before the current pandemic laser-focused the pharmaceutical industry’s attention on achieving a coronavirus vaccine, the spotlight on injectable drugs was bright thanks to the accelerating ... read more »

	Events

Microbial Identification for All: Exploring the MicroSEQ ID Microbial Identification System
Online – 12/09/2020
The MicroSEQ ID System is based on sequence analysis of ribosomal genes in bacteria and fungi. event details »

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

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