| ANALYTICS: DATA INTEGRITY |

Maintaining Lab Data Integrity

This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
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| QUALITY |

Preclinical Evaluation of Product Related Impurities and Variants

The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the shortcoming with the contemporary approaches.
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| DOWNSTREAM PROCESSING |

Industry Adoption of Single-Use Systems Remains Low

Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.
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| CELL AND GENE THERAPY MANUFACTURING |

FDA Framework Spurs Advanced Therapies

Clarity on the application of existing regulations will accelerate development of cell and gene therapies.
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| FACILITY DESIGN AND OPERATIONS |

Designing a Single-Use Biopharmaceutical Process

Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.
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| CONTAINER CLOSURES |

Container Closures: Leaving Nothing to Chance

As closure integrity testing moves from a probabilistic to a deterministic basis, designs are promoting improved control and reduced operator contact.
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| FROM THE EDITOR |

A New Business Model for Pharma?

Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.
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| REGULATORY BEAT |

Opportunities and Obstacles for Generic Drugs

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
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| ASK THE EXPERT |

Applying GMPs in Stages of Development

Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety.
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