Pharmaceutical Technology, Dec 2, 2013 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Dec 2, 2013
Cover Story
Implementing QbD in Sterile Manufacturing
By Susan Haigney
Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.
Special Report
Industry Optimism Outweighs Personal Job Security
By Rita Peters
Pharmaceutical Technology's 2013 Employment Survey reveals some optimism for the industry's future performance, but ongoing concerns about individual job prospects.
Special Report
Uncertainty in the Workplace
By Rita Peters
Industry mergers, acquisitions and downsizing contribute to uncertainty in job security in the European bio/pharmaceutical market.
Peer-Reviewed
Establishing a Minimum Incubation Time for Biological Indicators
By John R. Gillis , John B. Kowalski , Gregg A. Mosley , Garrett Krushefski , Kurt J. McCauley , Philip M. Schneider
The industry lacks an accepted method for establishing a minimum incubation time (MIT) of less than seven days for biological indicators (BIs). The authors propose an MIT method that provides a means for reproducible determination of BI grow-out time.
API Synthesis & Manufacturing
Tracking Innovation in New Molecular Entities of 2013
By Patricia Van Arnum
A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.
Troubleshooting
Using Analytical Techniques to Examine Tablet Sticking
By Rob Blanchard , Abdennour Bouhroum
Analytical tests, correlated with statistical techniques, are used to predict material behavior.
Regulation & Compliance
Deficiencies Found in API Inspections
By Carmelo Rosa , Alicia Mozzachio , Paula R. Katz
PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
By Sean Milmo
The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).
Regulatory Watch
Opioid Regulation Challenges FDA and Manufacturers
By Jill Wechsler
New policies and products seek to maintain access to pain medicines while curbing rampant abuse.
Outsourcing Outlook
Climate Change in Outsourcing
By Jim Miller
Ongoing changes create new opportunities for CROs and CMOs.
Global Feature
Clinical Trials Head East to Asia
By Jane Wan
The rising cost of drug development and the decreasing proportion of drug-naive population in the US and European markets are driving international pharmaceutical companies to consider emerging markets as a location to conduct their clinical trials. Asia stands out among the emerging markets given its double-digit growth rates.
Biotechnology Innovation and Growth in Israel
By Jill E. Sackman , Michael Kuchenreuther
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
Ask the Expert
Drug Manufacturing Focus: Why India?
By Siegfried Schmitt
Siegfried Schmitt, principal consultant at PAREXEL, discusses the state of drug manufacturing in India.
Industry Leaders: Q&A
Q&A with Brian Galliher, Cook Pharmica
By Melanie Sena
Brian Galliher of Cook Pharmica discusses visual inspection systems.
Product Spotlight
Tablet Tooling Coating Reduces Formulation Sticking
By Melanie Sena
Tablet Tooling Coating Reduces Formulation Sticking
Rail-Mounted Fluid Bed Dryers Allow Cleaning Access
By Melanie Sena
Rail-Mounted Fluid Bed Dryers Allow Cleaning Access
Bioreactor Functions as Perfusion Mimic
By Melanie Sena
Bioreactor Functions as Perfusion Mimic
Low Feed Rate Feeder Designed for Pharmaceutical Processes
By Melanie Sena
Low Feed Rate Feeder Designed for Pharmaceutical Processes
Guest Editorial
Inspiring the Next Generation
By Timothy J. Smith
Scientists can share time and pharmaceutical knowledge with high school students.

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Which of the following business challenge poses the greatest threat to your company?
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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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