BioPharm International’s August Issue: Industrializing Cell and Gene Therapies; Monitoring and Control of Inline Dilution Processes

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September 2019
Volume 32, No. 9

| COVER STORY |

Putting Biopharma Stability Testing Under the Microscope

Felicity Thomas

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.
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| UPSTREAM PROCESSING |

Cell–Culture Advances Test Bioreactor
Performance Models

Cynthia A. Challener

The evolution of cell–culture technology is driving the need for improvements in modeling solutions.
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| CELL AND GENE THERAPIES|

Seeking Solutions for Large-Scale GMP Viral Vector Manufacturing

Cynthia A. Challener

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

| QUALITY |

Best Practices for Studying Stability in Biologics

Susan Haigney

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

Methods Accelerate Biosimilar Analysis

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 |

Improving Oligonucleotide Analysis

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 |

Container Closure Integrity Testing of Finished Sterile Injectable Product

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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Process Development Forum
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| DOWNSTREAM PROCESSING |

What's New in Manufacturing: Process Chromatography

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 |

Biologics Continue to Grow and Create Outsourcing Opportunities

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 |

Plan Now to Share Your Expertise in 2020

Rita C. Peters

The editors welcome technical article contributions from biopharma industry experts.
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| REGULATORY BEAT |

| ASK THE EXPERT |

Developing an Effective Contamination Control Strategy

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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