Pharmaceutical Technology, Mar 2, 2013 - Pharmaceutical Technology

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PharmTech

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PharmTech Europe

Pharmaceutical Technology, Mar 2, 2013
Cover Story
Advances in PAT for Parenteral Drug Manufacturing
By Patricia Van Arnum
Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.
Advancing analytical testing and instrumentation for biopharmaceuticals
By Patricia Van Arnum
Instrument manufacturers and testing service providers are offering improved tools to biologic charaterization.
Special Section: Quality by Design
The Role of Analytical Science in Implementing Quality by Design
By Phil Nethercote , Graham Cook , Moheb Nasr , Siegfried Schmitt , Lucinda Buhse
The authors present topics discussed and conclusions that resulted from the PDA QbD workshop.
Validation
The Lifecycle Change of Process Validation and Analytical Testing
By Susan Haigney
Industry experts discuss the effect FDA's 2011 process validation guidance has had on industry.
Drug Delivery
Nanoparticles:Facilitating Targeted Drug Delivery in Cancer Therapy
By Adeline Siew, PhD
Engineering nanoparticles with optimal properties for use in cancer therapies.
Troubleshooting
Sterilizing with Nitrogen Dioxide
By Evan Goulet
Room-temperature sterilization using nitrogen dioxide gas benefits parenteral drugs.
API Synthesis and Manufacturing
Navigating the Global Manufacturing Supply Chain
By Patricia Van Arnum
As the strategic value of emerging markets increase, pharmaceutical companies increase their R&D and manufacturing investments.
Peer-Reviewed Research
Isolation of Pharmaceutical Impurities and Degradants Using Supercritical Fluid Chromatography
By Jeffrey P. Kiplinger , Paul M. Lefebvre , Michael J. Rego , John H. Tipping
The authors demonstrate that using supercritical fluid chromatography offers distinct advantages in speed and in clean isolation of the desired peaks.
Foam Granulation
By Michael R. Thompson , Paul J. Sheskey
The authors review developments in wet granulation using a twin-screw extruder.
Editor's Comment
Catching Up
By Rita Peters
QbD paradigm advances process understanding in development and manufacturing.
BioForum
Relevance Regained
By Simon Chalk
Companies risk drowning in alphabet soup if the latest three-letter acronym improvement strategy isn't clearly linked to business strategy.
In the Spotlight
Product Spotlight: Automation/IT/Process Control
New product reviews for March 2013, featuring automation, IT, and process control systems.
Regulation & Compliance
Regulatory Roundup
A roundup of regulatory news from across the global pharmaceutical industry.
Vaccine Innovation Yields New Products and Processes
By Jill Wechsler
Vaccine development is benefiting from manufacturing advances and support for global health.
Europe and the United States to Negotiate a Free-Trade Agreement
By Sean Milmo
Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.
Inside IPEC
Conforming to the IPEC CoA Guide
By Juanita Garofolo , David Klug , David R. Schoneker
Past IPEC-Americas excipient qualification committee chairs highlight changes to the IPEC guide on certificates of analysis for bulk excipients.
CMC Troubleshooting
Measuring API Particle Size Distribution
By Ann Newman, PhD
Visual mapping can provide a particle-size distribution estimate.
Global Feature
Report from Brazil
By Hellen Berger
Brazil's major vaccine producer innovates with stem-cell research.
Outsourcing Outlook
Outsourcing Nontraditional Protein Expression Systems
By Eric Langer
Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.
Ask the Expert
Adhering to ICH Q7 for GMPs
By David Elder
FDA's requirements for API manufacturers in regards to ICH Q7.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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