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Pharmtech
September 2019
Volume 31, No. 9
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| COVER STORY |

Scaling Up Right the First Time

Agnes Shanley

Front-end focus and new approaches are speeding scale-up and reducing costs, while scale-down and scale-out become increasingly important.
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|API SYNTHESIS & MANUFACTURING|

Seeking Solutions for Large-Scale GMP Viral Vector Manufacturing

Cynthia A. Challener

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

The Road to Real-Time Release: At-line NIR Testing

Anna Novikova

At-line NIR measurements can replace a laboratory HPLC measurement for API content.
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| PEER-REVIEWED RESEARCH |

Inhalation Drug Delivery: The Impact of Particle Size Reduction

Andreia Lopes, Raquel Barros, and Sérgio Silva

Research compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.
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| QUALITY |

Stability Indicating Methods for Aluminium Adsorbed Vaccine Products

Wendy Saffell–Clemmer and Elizabeth Joseph

The authors provide an introduction to aluminium adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminium vaccine release and stability analysis.
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| ANALYTICS |

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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| BIOPROCESSING |

Cell–Culture Advances Test Bioreactor Performance Models

Cynthia A. Challener

The evolution of cell-culture technology is driving the need for improvements in modelling solutions.
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| BREXIT PREPARATIONS |

The Big Deal Behind the 'No-Deal' Scenario

Felicity Thomas

As a potential 'no-deal' Brexit looms, pharma companies and industry bodies are preparing for the worst–case scenario.
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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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| EDITOR'S COMMENT |

Pharma's Got Talent?

Felicity Thomas

Government statistics show that pharma can be an illustrious career for graduates, which must be taken advantage of by industry to avoid skills shortages.
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| EUROPEAN REGULATORY WATCH |

EMA's Regulatory Impact: Not Yet in its PRIME

Sean Milmo

EMA is seeking ways to improve the effectiveness of its PRIME scheme, so that scientific innovations and new technologies more readily lead to novel medicines.
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| 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.
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| EVENTS |

Particles in Injectables Conference

Berlin, Germany
24–25 September 2019

#PharmaGlass – free workshop: introduction to the use, analysis and verification of glass primary packaging

Sheffield, UK
9 October 2019

Wearable Injectors and Connected Devices Conference 2019

London, UK
9–10 October 2019

more events

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