| BIOSIMILARS |
Mario DiPaola, Indu Javeri
Effective application of mass–spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
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| ANALYTICAL METHODS |
Anjali Alving
Oligonucleotides, which are classified as both small molecules and biomolecules, pose unique analytical challenges. High–resolution mass spectrometry is becoming a method of choice for their development.
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| OPERATIONS |
Derek Duncan
As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.
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| DOWNSTREAM PROCESSING |
Lauren Lavelle
The latest advances in process chromatography include pre–packed chromatography columns, process characterization kits, fast protein liquid chromatography systems, and mixed–mode chromatography resins.
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| OUTSOURCING |
Susan Haigney
CDMOs are adding facilities and services to their portfolios in anticipation of the biologics industry's continued growth.
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| FROM THE EDITOR |
Rita C. Peters
The editors welcome technical article contributions from biopharma industry experts.
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| REGULATORY BEAT |
Jill Wechsler
Industry and regulators seek global system that reduces regional differences.
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| ASK THE EXPERT |
Siegfried Schmitt
Providing regulators with a holistic approach to addressing deficiencies is the best response to an inspection, says Siegfried Schmitt, PhD, vice–president, technical, Parexel Consulting.
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