| SCALE UP |

Batch or Continuous? Ask the Right Questions During Scale Up

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.
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| PEER-REVIEWED |

Defining and Managing Raw Manufacturing Data

Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.
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| ANALYTICS |

Leveraging Computational Models of Glycosylation for Biopharma QA

Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
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| SUPPLY CHAIN |

On the Right Track

Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.
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| GOOD LABORATORY PRACTICES |

Good Laboratory Practices: Getting on the Same Page

Quality and compliance depend on the right approaches to training, standard operating procedures, and validation. More tools are available to help ensure success.
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| FROM THE EDITOR |

Pharma Facilities Still Have a Lot to Learn

FDA's annual manufacturing report card shows more quality compliance is needed.
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| US REGULATORY WATCH |

FDA Advances New Approach to Drug Quality Assessment

New agency leadership is pressed to promote innovation while addressing safety and quality issues.
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| ASK THE EXPERT |

Quality Agreements and Out-of-Specification Investigations

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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