| FORMULATION |

Considering Protein and Peptide Delivery

New approaches seek to address formulation and delivery challenges for these complex molecules.
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| PEER-REVIEWED RESEARCH |

Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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| ANALYTICS |

The Solubility Conundrum

Early adoption of the right approach to address solubility can deliver significant benefits.
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| BIOPHARMACEUTICAL MANUFACTURING |

Continuous Processing: Challenges and Opportunities of Virus Filtration

Requirements for virus filtration must be considered in developing continuous downstream processes.
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| PROCESS DEVELOPMENT |

Proper Process Development and Drug Shortages

Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.
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| EUROPEAN REGULATIONS |

Regulatory Divergence: The Burden of Brexit?

As Brexit rapidly approaches, the lack of clarity around the regulatory balance between the regions could lead to a reduction in standards.
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| EDITOR'S COMMENT |

Great Expectations

The new year has started with a bang in terms of mergers and acquisitions.
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| EUROPEAN REGULATORY WATCH |

A Year of Possible Regulatory Upheaval and Paralysis

This coming year could see a combination of regulatory uncertainty and inactivity for the pharma industry, mainly as a result of Brexit.
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| ASK THE EXPERT |

Global Inspection Harmonization

Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.
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