BioPharm International-09-01-2019

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.

Particulates or aggregates are a notable challenge for injectables, but there are several methods available to help with identification during formulation and development.

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.

As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.

The latest advances in process chromatography include pre-packed chromatography columns, process characterization kits, fast protein liquid chromatography systems, and mixed-mode chromatography resins.

Industry and regulators seek global system that reduces regional differences.

Industry experts discuss the challenges and regulations of setting up a CGMP-compliant stability testing program.

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.

CDMOs are adding facilities and services to their portfolios in anticipation of the biologics industry’s continued growth.

The editors welcome technical article contributions from biopharma industry experts.

Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.

Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost.

The evolution of cell-culture technology is driving the need for improvements in modeling solutions.

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