March 2017
Volume 41, No. 2 |
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| COVER STORY |
Cynthia A. Challener
Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.
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| PEER-REVIEWED RESEARCH |
Pramote Cholayudth
This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.
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| EXCIPIENTS SOURCING |
Cynthia A. Challener
Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety.
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| FORMULATION |
Beata Vladovicova
More agile techniques are improving the development of multiparticulate drug-delivery systems.
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PharmTech March Issue
Partnerships in Outsourcing
Be sure to check out this month's Partnerships in Outsourcing special issue for articles on serialization, cold chain, quality metrics, and more!
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| EQUIPMENT MAINTENANCE |
Elizabeth Rivera, Dijana Hadziselimovic, Paul Lopolito
Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.
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| EXTRACTABLES AND LEACHABLES TESTING |
Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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| REGULATORY CONSIDERATIONS |
Jizhou Wang, Neeru Takiar, Huyi Zhang, David J. Skanchy
The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.
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| COLD CHAIN DISTRIBUTION |
Agnes Shanley
Longer packouts are becoming the rule, as logistics service providers and sponsors gain experience planning logistics for clinical trials involving novel therapies.
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Agnes Shanley
An example of a new cold chain temperature-controlled shipping technology is Cocoon, which was commercialized in November 2016 and designed for use with pallet-sized shippers.
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| TROUBLESHOOTING |
Jennifer Markarian
Pump systems must be designed to meet the needs of specific processes, including preventing cross-contamination and damage due to shear forces.
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| US REGULATORY WATCH |
Jill Wechsler
User fee reauthorization is crucial to implementing the Cures Act and refining the approval process.
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| OUTSOURCING OUTLOOK |
Gil Roth
The outlook for the CMO and CDMO industry may be affected by ever-changing politics.
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| ASK THE EXPERT |
Susan J. Schniepp
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
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| FROM THE EDITOR |
Rita C. Peters
Reducing regulatory roadblocks requires more than the stroke of a pen.
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| PRODUCT SPOTLIGHT |
The RA802 Pharmaceutical Analyzer from Renishaw is a compact benchtop Raman imaging system that enables users to formulate tablets by speeding up the analysis of tablet composition and structure.
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The FlowCam 8100 particle imaging and analysis system from Fluid Imaging Technologies features a camera that can capture images at up to 120 frames per second and high-resolution digital images of individual particles and microorganisms measured in real-time based on their actual size and shape.
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The 10-gallon Double Planetary Mixer and Discharge System from Ross, Charles & Son has heavy-duty helical mixing blades, designed for high-viscosity pastes, gels, and putty-like materials.
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The firmware version 2.20 for the Excellence Moisture Analyzers HX204 and HS153 from Mettler Toledo includes enhanced user-rights assignment capabilities.
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| Events |
March 5–9, 2017
March 13–15, 2017
May 16–18, 2017
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