| PEER-REVIEWED RESEARCH |

Approaches to Reduced Sampling and Testing for Starting Materials

Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.
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| MANUFACTURING |

Visualization Enhances Facility Design

Can virtual reality unlock the biopharma manufacturing capacity challenge?
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| QUALITY/REGULATIONS |

Design of Experiments Gains Ground in Biopharma Development

Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development, as equipment evolves and use of PAT increases.
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| ANALYTICS |

Meeting E&L Expectations

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.
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| EDITOR'S COMMENT |

‘Polling’ All the Way

As the UK heads to the polls for an unusual December general election, industry issues manifestos on medicines while Europe rejoices some movement … finally.
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| EUROPEAN REGULATORY WATCH |

The Challenges for Regulators in the Digital Age

Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.
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