| LIFESTYLE MANAGEMENT |

Analytical Procedure Lifecycle Management: Current Status and Opportunities

The authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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| TECHNOLOGY 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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| TRAINING AND SOPS |

Make Training a Strategic Asset: Five Key Steps

Simplified role-based training can lead to better quality metrics and compliance.
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| RISK ASSESSMENT |

Impact of Non-Compliance on the American Healthcare Consumer

GMP non-compliance can spill over and impact patient access to life-saving medications.
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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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| COMBINATION PRODUCTS |

Autoinjector Training May Lead to Patient Adherence

Using training devices may ease patient anxiety about using autoinjectors and prefilled syringes, potentially leading to improved patient adherence.
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| TRANSDERMAL DRUG MANUFACTURING |

Manufacturing Considerations for Transdermal Delivery Systems

Drug and adhesive formulation are crucial to the development of microneedle patches for pharmaceutical transdermal delivery systems.
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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 CONTROL |

Microbial Identification Strategies for Bioburden Control

Microbial identity data can be critical for determining contamination sources.
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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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| FROM THE EDITOR |

The Key Word: Quality

Bio/pharma companies cannot spell success without solving all elements of quality programs.
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| US REGULATORY WATCH |

Quality Manufacturing Key to Reducing Drug Shortages

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.
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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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