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October 30, 2017

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Drug Discovery

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Degree of Crystallinity

Drug Production

cGxP
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Quality Control

Counterfeit Detection
Stability Study
Polymorph Confirmation

	Industry News

HTX-011 Granted FDA Fast Track Designation to Reduce Postoperative Pain

Kitov Announces Trial for KIT-302 Successfully Meets Primary Endpoint

EB8018 Successfully Completes Phase I Study in Healthy Volunteers

Statement from FDA Commissioner on Trump Administration’s Efforts to Address Opioid Crisis

First Subject Dosed in Study of ORIC-101 with Planned Development for Oncology

FDA Grants Orphan Drug Status for LBS-008 for Stargardt Disease

	Featured Articles

Data Integrity Issues in Microbial Testing Data Integrity Issues in Microbial Testing A lack of data integrity often is “just fraud,” says Howard Sklamberg, FDA deputy commissioner for ... read more »

Batch, Continuous or “Fake/False” Continuous Processes Batch, Continuous or “Fake/False” Continuous Processes Use of “Fake and/or False” in our vocabulary has become very pervasive since 2016. I thought it ... read more »

	Featured Announcements

Learn How Acoustic Liquid Handling Can Improve Your Bioassay Workflows
Webinar
In this webinar, we will compare acoustic droplet ejection (ADE) technology to standard tip-based ... read more »

	Featured Video

Webinar: Using TOC and Conductivity for Cleaning Validation, Verification and Monitoring
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 ... read more »

Watch Video: Ashland Pharma Bench Tip - Continuous Processing
Watch Video: Ashland Pharma Bench Tip - Continuous Processing
Watch Video: Ashland Pharma Bench Tip - Continuous Processing read more »

	Featured Products

HyClone CCM5 Cell Culture Media
read more »

Pegasus 4D GCxGC-TOFMS
read more »

	Featured Whitepaper

Whitepaper: Determination of Stress Conditions for Microorganisms for use in Validation of Milliflex Rapid Detection System
Determination of Stress Conditions for Microorganisms for use in Validation of Milliflex Rapid Detection System
In the pharmaceutical/biotechnology manufacturing industry, most of the microbial contaminants are believed to be stressed. read more »

Whitepaper: Applicability of the LyoCapsule Mini Freeze Dryer for Pharmaceutical Product Formulation and Process Development
Applicability of the LyoCapsule Mini Freeze Dryer for Pharmaceutical Product Formulation and Process Development
The development of biopharmaceuticals often requires lyophilized formulations to produce stable drug products. read more »

	Events

Solvent-less Barrier Film Coatings
Online – 11/01/2017
This webinar will provide an overview of a new dry powder polymer layering process which allows for the application of an ethylcellulose barrier film ... event details »

Combining Particle and Microbial Sensors to Fully Meet Regulatory Requirements
Online – 11/08/2017
In this webinar you will learn how to incorporate particle and microbial sensors into Environmental Monitoring Systems. Monitoring of nonviable and ... event details »

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