January 2016
Volume 40, No. 1 |
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| FOCUS |
Rita C. Peters
Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?
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| FORMULATION |
Adeline Siew, PhD
Liquid formulations in hard-shell capsules or softgels are becoming a popular option for HPAPIs because of advantages such as improved safety and lower risk of potential exposure and product cross contamination.
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| PEER-REVIEWED RESEARCH |
Michel Crevoisier, Ester Lovsin Barle, Andreas Flueckiger, David G. Dolan, Allan Ader, Andrew Walsh
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
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PharmTech January Issue
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| EUROPEAN REGULATORY WATCH |
Sean Milmo
Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.
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| SERIALIZATION |
Agnes Shanley
Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.
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| PACKAGING FORUM |
Hallie Forcinio
Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.
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| GREEN MANUFACTURING |
Jennifer Markarian
Sustainable manufacturing practices at GSK aim to reduce waste, energy, and water use across the value chain.
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| THE BIG PICTURE FOR 2016 |
Agnes Shanley
Synthetic biology promises to drive tomorrow’s therapies, while continuous processing is already being used in some new drugs.
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Susan Haigney
Industry experts discuss what the outsourcing market holds for 2016.
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Jill Wechsler
The bio/pharmaceutical industry will face increased scrutiny of product quality and cost drivers.
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| HEALTH-BASED EXPOSURE LIMITS |
Andrew Teasdale, Bruce D. Naumann, Gretchen Allison, Wendy Luo, Courtney M. Callis, Bryan K. Shipp, Laura Rutter, Christopher Seaman
The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.
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| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Nanoscale catalysts and engineered nanoparticles may have a big impact on
small-molecule pharmaceuticals.
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| TROUBLESHOOTING |
Oliver Stauffer
The revised USP Chapter <1207> Sterile Product Packaging—Integrity Evaluation gives best practices for obtaining reliable data in container closure integrity testing and recommends quantitative deterministic methods rather than probabilistic methods.
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| ASK THE EXPERT |
Siegfried Schmitt
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.
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| VIEWPOINT |
Rita C. Peters
Infrastructure and payer decisions will determine drug choices in emerging and developed regions.
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| INDUSTRY PERSPECTIVE |
Anil Kane
Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development.
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| PROCESS VALIDATION |
Patricia Santos-Serrao
The author discusses the collection and evaluation of data part of FDA’s definition of process validation.
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| Webcasts |
On Demand
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
On Demand
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 |
Tablet Coating
Blow Fill Seal for Aseptic Processing
Cell Therapies
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| Events |
February 2-4, 2016 | New Orleans, LA
March 14-16, 2016 | San Antonio, TX
May 23, 2016–May 25, 2016 | Berlin, Germany
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