| TECH TRANSFER |

Tech Transfer: Tearing Down the Wall

Tech transfer is evolving into close collaboration and communication, as potential problems are considered sooner and new technology is applied.
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| API SYNTHESIS & MANUFACTURING |

Fighting Bacterial Resistance with Biologics

Antibody-based drugs offer new mechanisms of action and greater specificity.
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| MANUFACTURING |

Manufacturing Considerations for Transdermal Delivery Systems

Drug and adhesive formulation are crucial to the development of microneedle patches.
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| SCALE UP |

Scaling Up and Launching Solid-Dosage Drugs

Boehringer Ingelheim plans to develop and test new strategies at its Solids Launch Facility.
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| BIOBURDEN REDUCTION |

Microbial Identification Strategies for Bioburden Control

Microbial identity data can be critical for determining contamination sources.
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| PROCESS OPERATIONS |

Improving Production: How IT, OT, and Quality Can Collaborate

Different functional groups must work together to get the most value from existing plant data.
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| OUTSOURCING |

Contract Organizations Expanded in Autumn

CMOs and CDMOs made investments in new and expanded facilities and services in the last quarter of 2018.
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| EDITOR'S COMMENT |

The Good, The Bad, and The Brexit

Taking stock on the 'big-ticket' news items, both good and bad, from the past 12 months.
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| EUROPEAN REGULATORY WATCH |

Relocating EMA: A Far from Ideal Situation

EMA's relocation to Amsterdam and resulting staff losses could severely weaken the agency’s role as a leading medicines regulator.
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| ASK THE EXPERT |

Investigation Timeliness vs. Thoroughness: Finding the Right Balance

A required time frame should not be the driving force behind root cause investigations, says Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished fellow, Regulatory Compliance Associates.
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