American Pharmaceutical News In Review

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November 27, 2017

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Detect viral contamination in your mAb process

FDA and EMA guidance documents outline virus testing strategies and recommendations; their expectation is that no virus should be detected in production processes.

Traditional tests for adventitious viruses offer opportunities for broad detection of diverse viruses. New testing technologies such as Next Generation Sequencing (NGS) open doors for more rapid and sensitive viral detection.

	Industry News

ERS Genomics Provides Update on Patent Interference Process

Puma Biotechnology, Specialised Therapeutics Asia Enter into Exclusive Licensing Agreement

U.S. Stem Cell Responds to FDA’s Regenerative Medicine Guidelines

NJ AG Porrino Announces Amended Insys Complaint

WHO Announces New Global Commitment to End TB

Faslodex, Abemaciclib Receives FDA Approval for Treatment of Advanced Breast Cancer

	Featured Articles

Polarization-Resolved Raman Spectroscopy for Pharmaceutical Applications Polarization-Resolved Raman Spectroscopy for Pharmaceutical Applications Polarization-resolved Raman spectroscopy has great potential as a means of process analytical ... read more »

Kinetic and Thermodynamic Profiling in Drug Discovery: Promises, Challenges and Outlook Kinetic and Thermodynamic Profiling in Drug Discovery: Promises, Challenges and Outlook Over the last decade, there has been an increased awareness on kinetic and thermodynamic profiling ... read more »

	Featured Video

Webinar: Dry heat depyrogenation – the guidelines and practical approach
Webinar: Dry heat depyrogenation – the guidelines and practical approach
Recently issued, there is a new series of USP chapters (informational) on depyrogenation processes, and more specifically on dry-heat depyrogenation. ... read more »

Watch Now: BASF Skin Delivery Platform with Amy Ethier
BASF Skin Delivery Platform with Amy Ethier
BASF Skin Delivery Platform with Amy Ethier read more »

	Featured Whitepaper

Whitepaper: Analysis of Two API Products Using UV Spectrophotometry
Analysis of Two API Products Using UV Spectrophotometry
UV Spectrophotometry has traditionally been a simpler and less time and labor consuming method for analyzing dissolution testing samples. read more »

White Paper: USP compliance for Total Organic Carbon Analysis
USP <661> compliance for Total Organic Carbon Analysis
The Pharmaceutical Industry is heavily dependent on plastic packaging material to bring products to market. read more »

	Events

In-depth Insight on Analysis of Microbial Identification Data Generated by Genotypic Method
Online – 11/29/2017
Using molecular techniques or genotypic methods, such as PCR and Sanger sequencing for microbial identification delivers results that traditional ... event details »

West Coast World Vaccine & Immunotherapy Congress
San Diego, CA – 11/30/2017
On the back of our extremely successful World Vaccine Congress series in D.C. and Europe, we’re bringing to you our new West Coast World Vaccine & ... event details »

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