American Pharmaceutical News In Review

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September 01, 2017

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Upcoming Webinar: Using TOC and Conductivity for Cleaning Validation, Verification and Monitoring

Companies that perform manual, automated or CIP cleaning of their production equipment are required to demonstrate compliance with regulatory requirements for effective removal of residues. Still many of these companies use historical limits and complex test methods.

	Industry News

Thermo Fisher Scientific Completes Acquisition of Patheon

FDA Approves New Antibacterial Drug

FDA Approves First U.S. Treatment for Chagas Disease

FDA Accepts Pegvaliase BLA, Grants Priority Review Designation

Lilly to File Baricitinib Resubmission to U.S. FDA before end of January 2018

Boehringer Ingelheim Receives FDA Approval for Cyltezo

	Featured Articles

Microbiology Roundtable Microbiology Roundtable Current issues companies are dealing with include aging technology within their laboratories; ... read more »

Improving Microbial Cryopreservation Methods Improving Microbial Cryopreservation Methods The cryopreservation process can be stressful to sensitive microorganisms, including clinical ... read more »

	Featured Video

Webinar: Good Manufacturing Practices for Aseptic Filling of Biopharmaceuticals
Webinar: Good Manufacturing Practices for Aseptic Filling of Biopharmaceuticals
Sterilization is a critical process that packaging components undergo when processed via aseptic conditions. There are various sterilization processes... read more »

Watch Poster Video: Comparing the Quality of Different Glass Types-The inner surface chemistry of Wheaton glass
Watch Poster Video: Comparing the Quality of Different Glass Types-The inner surface chemistry of Wheaton glass
Watch Video: Comparing the Quality of Different Glass Types-The inner surface chemistry of Wheaton glass read more »

	Featured Products

Gemini HPLC Columns
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SARTOFLOW Alpha plus SU Filtration System
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	Featured Whitepaper

Development and applications of novel, highly sensitive fluorescent dyes for N-glycan analysis
Development and applications of novel, highly sensitive fluorescent dyes for N-glycan analysis
Glycosylation is one of the key critical quality attributes of monoclonal antibody–based biotherapeutics. Glycosylation changes can impact a biological drug’s safety, efficacy, clearance, and ... read more »

The Use of EDX Fluorescence Spectrometry for Pharmaceutical Elemental Impurity Analysis Based on USP
The Use of EDX Fluorescence Spectrometry for Pharmaceutical Elemental Impurity Analysis Based on USP <735>
In May 2015, the United States Pharmacopeia (USP) established general chapter <735>, permitting the use of X-ray Fluorescence (XRF) Spectrometry in pharmaceutical testing for elemental impurities. Perhaps ... read more »

	Events

CE in the Biotechnology & Pharmaceutical Industries
Boston, MA – 09/17/2017
CE in the Biotechnology & Pharmaceutical Industries: 18th Symposium on the Practical Applications for the Analysis of Proteins, Nucleotides and Small ... event details »

FierceBiotech’s Drug Development Forum
Boston, MA – 09/25/2017
Attendees of FierceBiotech’s 2nd Annual Drug Development Forum will obtain essential funding strategies and more productive R&D through executive-... event details »

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