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August 23, 2019

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[Webinar] Microbial Identification via DNA-Sequencing Method to Support Risk Mitigation Strategies

The utilization of Microorganism Identification through DNA sequencing provides an in depth and comprehensive view of the variety of organisms that may pose a risk to controlled environments or final product. Discussion of standards requiring characterization/identification and techniques of a genotypic microbial identification method will be covered.

	Industry News

FDA Grants BeiGene’s Lymphoma Treatment Priority Review
BeiGene, Ltd. has announced that the U.S. Food and Drug Administration (FDA) has accepted the ... read more »

Biotech Conagen Acquires Production Platform of Therapeutic Proteins
Conagen, a vertically integrated synthetic biology company located in Boston's biotech corridor, has... read more »

AstraZeneca’s Stage IV Lung Cancer Drug Misses Primary Endpoint
AstraZeneca has announced final overall survival (OS) results from the Phase III NEPTUNE trial, a ... read more »

FDA Grants Astellas/Pfizer’s XTANDI® Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer
stellas Pharma Inc. and Pfizer Inc. have announced that the U.S. Food and Drug Administration (FDA) ... read more »

Propanc Biopharma Granted US Patent Covering Additional Composition Claims for PRP
Propanc Biopharma, Inc. has received a granted US patent from the United States Patent and ... read more »

Perrigo Announces Patent Litigation Settlement for the Generic Version of Nascobal® Nasal Spray
Perrigo Company has settled its Hatch-Waxman litigation relating to Nascobal® (Cyanocobalamin) ... read more »

	Featured Articles

Challenges in the Downstream Process of Gene Therapy Products Challenges in the Downstream Process of Gene Therapy Products Over the last few years, gene therapy (GT) has emerged as a promising medical tool to treat diseases... read more »

Realizing the Full Value of Clinician Engagement in Pharmaceutical Development and Manufacturing Realizing the Full Value of Clinician Engagement in Pharmaceutical Development and Manufacturing Adoption of ICH Q8-11 has provided a more structured way to define product Critical Quality ... read more »

	Featured Video

Watch Poster Video: Validation of an Automated Alternative Microbiology Method in the Age of Diverging Guidance
Validation of an Automated Alternative Microbiology Method in the Age of Diverging Guidance
Validation of an Automated Alternative Microbiology Method in the Age of Diverging Guidance read more »

Watch Video: Sievers Complete Pharma Solution
Sievers Complete Pharma Solution
Watch Video: Sievers Complete Pharma Solution read more »

	Featured Products

VITEK MS MALDI-TOF Mass Spectrometer for Microorganism Identification
read more »

MicraSpray MS 2500
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	Featured Whitepaper

Benefits of 2D-LC/MS/MS in Pharmaceutical Bioanalytics
Benefits of 2D-LC/MS/MS in Pharmaceutical Bioanalytics
This application demonstrates the 2D-LC/MS/MS analysis of cell supernatants from an in vitro cell suspension-based assay. Superior separation by 2D-LC allowed the analysis of 16 target metabolites ... read more »

A Guide to Developing an Effective Cleaning and Disinfection Program in Aseptic Environments
A Guide to Developing an Effective Cleaning and Disinfection Program in Aseptic Environments
Regulatory agencies require pharmaceutical manufacturers to control the environments in which they produce finished products to ensure they are free of contamination. read more »

	Events

Lyophilisation USA Conference
Boston USA – 10/23/2019
About Lyophilisation USA The SMi Group is pleased to invite you to the 5th Annual Lyophilization USA Conference arranged to take place on the 23rd ... event details »

Stability Testing Summit
Boston, MA – 09/23/2019
Come to the Stability Testing Summit on September 23-24, at the Hyatt Regency Boston Harbor in Boston, Massachusetts. The time has never been more ... event details »

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