February 2017
Volume 29, 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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| 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 Europe February Issue
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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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| 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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| 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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| OUTSOURCING OUTLOOK |
Gil Roth
The outlook for the CMO and CDMO industry may be affected by ever-changing politics.
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| GMP/GDP INSPECTIONS |
The authors look at challenges and considerations to continuously improve inspection efficiency.
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| REGULATORY WATCH |
Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.
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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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| EVENTS |
22–23, February 2017
8–10, March 2017
13–15 March 2017
more events
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