Pharmaceutical Technology, May 1, 2013 - Pharmaceutical Technology

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Pharmaceutical Technology, May 1, 2013
Articles
Big Pharma's Manufacturing Investments in Biologics
By Patricia Van Arnum
Despite overall manufacturing rationalization in the pharmaceutical/biopharmaceutical industry, the large pharmaceutical companies continue to invest in biologic-based manufacturing. The author provides an update in recent investment activity among the pharmaceutical majors in biologic-drug substance, vaccine, and parenteral drug manufacturing.
An Integrated Prefilled Syringe Platform Approach for Vaccine Development
By Kingman Ng , Ronald Malone , Changyun Xiong , Xuefeng Yi
The authors describe a holistic and integrated approach to focus on the linkage of the prefilled syringe with the four phases of product design, development, operation, and control.
Risk Mitigation and Microbial Control and Monitoring of Cleanrooms
By Karen S. Ginsbury
A control strategy can maintain a low level of particulates, and thereby a low bioburden, in cleanrooms
Containment-Verification Testing For Pharmaceutical Equipment Performance
By George S. Petroka
A Good Practice Guide from the International Society of Pharmaceutical Engineering provides a framework to assess how well pharmaceutical equipment contains hazardous APIs.
Applying Continuous-Flow Pasteurization and Sterilization Processes
By John Miles, PhD
High-temperature, short-time (HTST) pasteurization and ultra-high temperature (UHT) sterilization are potentially useful as part of the trend toward methods of continuous manufacturing of bio/pharmaceuticals.
Advancing Drug Delivery for Parenteral Applications
Researchers recently developed a drug-delivery system to mitigate problems associated with jet-injection drug delivery, and also improved on the design and operation of microscale actuators as a possible drug-delivery method.
Delivering Complex Drugs With Nanotechnology-Based Solutions
By Patricia Van Arnum
Parenteral drug delivery offers a variety of challenges but also opportunities. The author examines recent developments in nanotechnology-based drug delivery and other advances in injection-based drug delivery.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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