August 2016
Volume 40, No. 8 |
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| FOCUS |
Jennifer Markarian
PharmTech's 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.
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| SPECIAL FOCUS|
Pharmaceutical Technology Editors
New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.
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| PEER-REVIEWED RESEARCH |
Mohmed K. Anwer, Rehana Begum, Shaik Kalesha, Punna Venkateshwarlu
This paper describes a unique Prep-RP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).
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| 3D PRINTING |
Jennifer Markarian
Three-dimensional printing allows unique benefits to be built into solid-dosage forms.
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Jennifer Markarian
A Q&A with FDA to gain insight on FDA's views of three-dimensional printing and its regulation in drug manufacturing.
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| TECHNOLOGY MANAGEMENT |
Ranjit Thakur, Timo Simmen, Stefan Merkle, Ramanathan Venkataraman, Camal Handor, Roger van den Heuvel
A technology management process identifies and evaluates new technologies in biopharmaceutical manufacturing to aid business decisions.
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| CLEANING VALIDATION |
Andrew Walsh, Michel Crevoisier, Ester Lovsin Barle, Andreas Flueckiger, David G. Dolan, Mohammad Ovais
Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.
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| FORMULATION |
Adeline Siew, PhD
Industry experts discuss key considerations in the development of orally disintegrating tablets.
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| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Enzymatic catalysis offers pharma manufacturers a way to implement the Principles of Green Chemistry.
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| TROUBLESHOOTING |
Frank Generotzky, Martin Tuckermann
The design of Baxter BioPharma Solutions' aseptic filling lines provides a case study in customizing containment systems for multi-product lines.
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|GOOD DISTRIBUTION PRACTICES|
Agnes Shanley
Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
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Agnes Shanley
Recent revisions to the European Union's good distribution practices, which were updated in 2013, reflect increased regulatory focus on the supply chain.
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| REGULATORY WATCH|
Jill Wechsler
Regulators and manufacturers address economic and ethical issues for scarce medicines.
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| OUTSOURCING |
Eric S. Langer
CMOs are working hard to improve performance by investigating new technologies for filtration and purification.
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| ASK THE EXPERT |
Susan J. Schniepp
Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.
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| FROM THE EDITOR |
Rita C. Peters
Congressional partisanship creates noise, but no funding for Zika virus research.
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| PRODUCT SPOTLIGHT |
The rotary lump breaker unit from Ajax Equipment comprises a screw feeder with sifting screens and collecting conveyor for a gentle lump breaking action on pharmaceutical powders.
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The Titan Syringe Pump from Syrris is a continuous flow chemical processing module suitable for lab-, pilot-, and production-scale applications.
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The Ross SysCon Portable Pumping System is capable of handling laminar and turbulent flow applications across a 26-element low pressure drop static mixer.
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The IsoBag from MilliporeSigma is used for the convenient transfer of contact and settle plates to production isolators.
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| WEBCASTS |
On Demand
The China Food and Drug Administration is to moving upgrade the country's bio/pharmaceutical industry including new manufacturing operations that meet Western standards to meet the medicinal needs of the nation's population. In this webcast, experts offer insight into opportunities for Western bio/pharmaceutical companies in China, and address lingering and unexpected questions about doing business there.
Sponsored by CPhI China
On Demand
In this educational webcast, learn about regulatory expectations and practical approaches to stability testing of drug substances and drug products for clinical trials, packaging, storage, and transportation.
Sponsored by SGS Life Science Services
more webcasts
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| Events |
September 12-14, 2016
September 18-21, 2016
October 4–6, 2016
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