August 2015
Volume 27, No. 8 |
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FOCUS
Jennifer Markarian
The 2015 survey says satisfaction is high and continuous manufacturing and PAT use are growing but may be limited by lack of knowledge and experience.
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PEER-REVIEW RESEARCH
Geoff Carr
A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes. / read more /
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PharmTech Europe August Issue
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FORMULATION
Michelle Frisch, Brian G. Ward
Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.
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OPERATIONAL EXCELLENCE
Agnes Shanley
CROs, CDMOs, and CMOs are embracing lean manufacturing, while Big Pharma is applying it, not so much for inventory management, but to improve supply chain visibility and control.
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LOGICTICS
Jennifer Markarian
Choosing the correct shipping solutions, including packaging, transportation mode, and monitoring, helps mitigate the risks inherent in global logistics.
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API SYNTHESIS & MANUFACTURING
Cynthia A. Challener
Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.
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REGULATORY WATCH
Sean Milmo
The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.
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Jill Wechsler
FDA and industry support global framework and collaborations to secure the supply chain.
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OUTSOURCING REVIEW
Eric Langer
Biopharma companies are outsourcing more jobs to cut costs.
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TROUBLESHOOTING
Jennifer Markarian
Paperless operations improve efficiency and increase assurance of product quality.
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ASK THE EXPERT
Susan J. Schniepp, Andrew Harrison
Experts discuss the requirements for a successful corrective action and preventive action (CAPA) system.
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BONUS ONLINE COVERAGE
Michael J. Kuchenreuther, PhD
China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.
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PharmTech editors
Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.
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Webcasts
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
Sponsored by: Patheon
As challenging new formulations are developed, how prepared is your team to optimize the formulation performance in encapsulation? This webinar will provide insight into improving productivity in the use of capsules for pharmaceutical products for both the formulator and supply chain. Capsule filling technologies, dosing options, excipients, capsule selection, and other factors will be discussed. An example from the field will illustrate encapsulation practices.
Sponsored by: Capsugel
Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by: SGS
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on pharmtech tv
Application of External Lubrication in Tablet Production
Feeding Powders in Pharmaceutical Processes
Focus on Biobetters
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Events
September 7–9, 2015 | Seoul, Korea
September 16-17, 2015 | Berlin, Germany
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