BioPharm International-09-01-2019

BioPharm International

Improving Oligonucleotide Analysis

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.

Dealing with particulates or aggregates in biologics

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.

Putting Biopharma Stability Testing Under the Microscope

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.

Container Closure Integrity Testing of Finished Sterile Injectable Product

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.

What’s New in Manufacturing: Process Chromatography

September 01, 2019

Features

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

More Predictable Post-Approval Change Policy on Horizon

September 01, 2019

Regulatory Beat

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Industry and regulators seek global system that reduces regional differences.

Best Practices for Studying Stability in Biologics

September 01, 2019

Features

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

Developing an Effective Contamination Control Strategy

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.

Biologics Continue to Grow and Create Outsourcing Opportunities

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.

Plan Now to Share Your Expertise in 2020

September 01, 2019

From the Editor

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The editors welcome technical article contributions from biopharma industry experts.

Seeking Solutions for Large-Scale GMP Viral Vector Manufacturing

September 01, 2019

Features

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

Methods Accelerate Biosimilar Analysis

September 01, 2019

Features

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

Cell-Culture Advances Test Bioreactor Performance Models

September 01, 2019

Features

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

BioPharm International, September 2019 Issue (PDF)

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.