| PEER-REVIEWED RESEARCH |
Chintan Patel, Sanjay Bandyopadhyay, and Gayatri C. Patel
In this article, the effect of freeze-thawing and high temperature on the stability of pegaspargase protein was studied. Differences in the degradation pathways for the storage conditions were identified, and manufacturing issues associated with the degradation are discussed.
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| CLEANING PROCESS |
Elizabeth Rivera and Dijana Hadziselimovic
Laboratory test methods evaluate cleaning agents and cleaning process design for non-dedicated chromatography columns systems.
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| CONTINUOUS MANUFACTURING |
Jennifer Markarian
Flexible batch sizes can optimize supply, but equipment processing challenges are still being addressed.
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| ANALYTICS |
Felicity Thomas
Characterizing particles and understanding bulk powder behaviour is critical to get the best pharma product.
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| OPERATIONS |
Derek Gallo and Sanjay Konagurthu
Successful technology transfer depends on the ability to anticipate risks and plan ahead.
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| EDITOR'S COMMENT |
Felicity Thomas
Uncertainty remains around the UK's departure from the EU, potentially causing irreparable damage to the bio/pharma sector.
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| EUROPEAN REGULATORY WATCH |
Sean Milmo
The European Commission has published a strategy that will form the basis for the European Union's policy on pharmaceuticals in the environment.
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| ASK THE EXPERT |
Susan J. Schniepp
A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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