BioPharm International
September 09, 2019
Features
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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.
September 01, 2019
Cover Story
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Particulates or aggregates are a notable challenge for injectables, but there are several methods available to help with identification during formulation and development.
September 01, 2019
Cover Story
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Stability testing for biologics is more complex than for small-molecule drugs, so companies should be aware of the potentially serious issues that can be costly and jeopardize drug development.
September 01, 2019
Features
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As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.
September 01, 2019
Features
32
9
The latest advances in process chromatography include pre-packed chromatography columns, process characterization kits, fast protein liquid chromatography systems, and mixed-mode chromatography resins.
September 01, 2019
Regulatory Beat
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Industry and regulators seek global system that reduces regional differences.
September 01, 2019
Features
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Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.
September 01, 2019
Ask the Expert
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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.
September 01, 2019
Perspectives on Outsourcing
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CDMOs are adding facilities and services to their portfolios in anticipation of the biologics industry’s continued growth.
September 01, 2019
From the Editor
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The editors welcome technical article contributions from biopharma industry experts.
September 01, 2019
Features
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Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.
September 01, 2019
Features
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Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.
September 01, 2019
Features
32
9
The evolution of cell-culture technology is driving the need for improvements in modeling solutions.
September 01, 2019
Issue PDF
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Click the title above to open the BioPharm International September 2019 issue in an interactive PDF format.