Pharmaceutical Technology, Nov 2, 2014 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Nov 2, 2014
Cover Story
Parenterals, Particulates, and Quality by Design
By Cynthia Challener, PhD
The parenteral manufacturing industry is taking action to address particulate contamination issues.
Featured Content
GMPs for Small-Molecule Drugs in Early Development: Workshop Summary-Part VI
By Q. Chan Li , Jackson Pellett , Michael Szulc , Mark D. Trone , Kirby Wong-Moon
The authors explore and define common industry approaches and practices when applying GMPs in early development.
Formulation
Injecting Highly Viscous Drugs
By Andy Fry
The author reviews the challenges in delivering macromolecule biologics.
DoE Provides Benefits, but Preparation Is Necessary
By Cynthia Challener, PhD
Defining critical parameters and processing large quantities of data can be a challenge.
Peer Reviewed
Considerations in Developing Sublingual Tablets—An Overview
By Muhammad Ashraf , Vilayat A. Sayeed
This review highlights relevant physicochemical drug properties and formulation design considerations critical to quality and performance of the sublingual tablets.
Regulatory Watch
New Era for Generic Drugs
By Jill Wechsler
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Tackling Drug Shortages
By Sean Milmo
Resolving the problem will require more communication between the industry and regulatory bodies.
API Synthesis & Manufacturing
Advances in Large-Scale Heterocyclic Synthesis
By Cynthia Challener, PhD
New practical approaches to the synthesis of complex heterocycles are reviewed.
Manufacturing
Continuous Solid-Dosage Manufacturing Platform Nears Prototype Installation
By Jennifer Markarian
A G-CON, GEA, and Pfizer collaboration developed a PCMM (portable, continuous, miniature, and modular) system to produce oral solid-dosage drugs.
Outsourcing Outlook
Outside Looking In
By Jim Miller
European CDMOs want into the US market, but entry options are limited.
Global Feature
Germany Post AMNOG: Insights for BioPharma
By Jill E. Sackman , Michael Kuchenreuther
The authors take a look at some of the recent developments in the German pharmaceutical market.
Troubleshooting
Using Flow Sensors to Monitor Process System Health
By Craig Correia
Using flow sensors, operators can monitor compressed-air use to help identify problems early and provides data for improving energy efficiency.
Quality by Design
A Robust CAPA System for a Global Supply Chain
By KR Karu
Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.
From The Editor
Hype vs. Health
By Rita Peters
Ebola Virus Disease (EVD) is a severe, often fatal disease that is transmitted human-to-human through bodily fluids.
Product Spotlight
Sleeves and Gauntlets Designed for Highly-Controlled Environments
Nitritex introduces BioClean BarrierPlus isolator and Restricted Access Barrier Systems sleeves and gauntlets designed for highly-controlled environments.
Biodecontamination System Reduces Cycle Times
Telstar's ionHP biodecontamination system is designed to use ionized hydrogen peroxide in aseptic processes.
Steritest Symbio Pumps Increase Productivity
EMD Millipore's Steritest Symbio Pumps are designed to create more reliable sterility testing in laminar flow hoods, isolators, and clean rooms.
Cleanroom Filtration System Minimizes Costs
Connect 2 Cleanrooms' mobile, adjustable cleanroom filtration system, HEPA-lite, provides localized filtered air.

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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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