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American Pharmaceutical News In Review
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May 11, 2020
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  How well do you understand ICH guidelines for Stability Testing?

Stability testing is a vital part of product development and is conducted throughout a product’s life cycle. Stability is part of a biotherapeutic’s quality target product profile, and results help analysts understand how critical quality attributes (CQAs) of both drug substances and products are influenced under specific conditions of temperature, relative humidity (RH), light, storage, pH, and other factors. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. LEARN MORE

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» Industry News
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  Today's COVID-19 News: May 8, 2020
Review the latest news and information on the Coronavirus Pandemic. read more »
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  FDA Grants Accelerated Approval to Capmatinib for Metastatic NSCLC
The FDA granted accelerated approval to capmatinib for adult patients with metastatic non-small cell... read more »
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  University of Oxford, Sound Pharmaceuticals Complete Phase 2 Bipolar Disorder Study
The University of Oxford and SPI announced the successful completion of a Phase 2a study testing SPI... read more »
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  Evelo, Rutgers, RWJ Submit IND for Study of EDP1815 as COVID-19 Treatment
Evelo , Rutgers, and RWJ announced the submission of an IND application for a clinical study of ... read more »
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  OSE Immunotherapeutics Announces COVID-19 Prophylactic Vaccine Program
OSE Immunotherapeutics announced its team of immunologists is actively working on the development of... read more »
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  FDA Grants EUA for Cardiac Monitoring in COVID-19 Patients
VitalConnect was granted EUA status by the FDA as part of the response to the COVID-19 pandemic. read more »

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» Featured Articles
Continuous Processing of Nanoparticles: An Emphasis on Liposomal Formulations
As succinctly stated by former FDA commissioner, Dr. Scott Gottlieb, and CDER Director, Dr. Janet ... read more »
An Interview with... Russ Miller Director, Business Development, Vectura
Drug development in general is in a strong phase, with FDA approval numbers also being very healthy.... read more »
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» Featured Announcements
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  The Evaluation, Implementation and Validation of Bringing Rapid Mycoplasma Testing In-House to Expedite Lot Release of Recombinant Protein Product
Webinar
Overview Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant ... read more »
» Featured Video
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  On-Demand Webinar: Continuous Improvement – Using a Handheld Raman Spectrometer for Quality Testing in Biopharmaceutical Manufacturing
In this webinar, you’ll learn what TruScan is and how it supports continuous improvement for biopharma manufacturers, applications using TruTools ... watch »
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  On-Demand Webinar: Dodge the Particle Panic: Visible and Subvisible ID Made Easy with Raman Spectroscopy and LIBS
In this webinar, Dr. Robin Sweeney will demonstrate how new hardware and software advances have made it even simpler to use Hound for identifying ... watch »

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» Featured Products
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  Diffucaps Customized Release Technology
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  MAS-100 ISO NT Microbial Air Sampler
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» Featured Whitepaper
Financing a cryo-EM laboratory
Establishing a cryo-electron microscopy (cryo-EM) laboratory requires substantial resources for equipment and infrastructure. Also, operating expenses have to be planned. You must consider several ... read more »
The Right Partner Can Improve Flexibility and Mitigate Risks from Forecast Inaccuracy in Biomanufacturing
Bioprocess Technology Consultants’ (BPTC) following analysis provides further insight and perspective on the key themes that emerge from the report and offers additional solutions to companies to ... read more »

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| Events
EVENT
  A 360 Overview of Data Integrity in Life Sciences
Online –  05/12/2020
Trustworthiness in data is critical for operations within the pharmaceutical and life sciences industries, whether it is for compliance, operational ...
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EVENT
  Sample Prep - An Optimized Workflow for Single-Cell Transcriptomics and Repertoire Profiling of Purified Lymphocytes from Clinical Samples
Online –  05/13/2020
Improper sample preparation during single-cell transcriptomic workflows can lead to detrimental cascades resulting in loss of precious samples.
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