PharmTech Europe September Issue: PharmTech Europe September Issue: Focusing on the Last Link; Can Artificial Intelligence Take the Next Step for Drug Repositioning?

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September 2018
Volume 30, No. 9

| COVER STORY |

Focusing on the Last Link

Agnes Shanley

As counterfeiting, API manufacturing issues, and illegal diversion increase vulnerability, could dispensers and even patients play a greater role in securing the pharma supply chain?
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| API SYNTHESIS & MANUFACTURING |

Can Artificial Intelligence Take the Next Step for Drug Repositioning?

Cynthia A. Challener

Existing software tools cannot take into account the complexity of disease.
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| FORMULATION |

Coating for Tastemasking

Adeline Siew, PhD

The level of tastemasking required will depend on the API properties and the dosage form design.
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PharmTech September Issue

| PEER-REVIEWED RESEARCH |

Rethinking Cleaning Validation for API Manufacturing

Chunfen Zhang, Dijana Hadziselimovic, Amy Thanavaro, Adeyinka Aina, Chris Edlin, Paul Lopolito

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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| MANUFACTURING: FILL/FINISH |

Risk-Averse Fill/Finish Industry Embraces Change

Iain MacGilp, Martin Reid

Single-use technologies, modular systems, and robots are on the rise.
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| CLINICAL TRIALS MANUFACTURING |

Clinical Manufacturing: Clearing Higher Hurdles

Agnes Shanley

Increasingly complex trial protocols have added to IMP manufacturing challenges.
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| FACILITY DESIGN |

Multi-Purpose Biopharmaceutical Manufacturing Facilities Part 1: Product Pipeline Manufacturing

Mark Witcher, Harry Silver

A multi-purpose biopharmaceutical manufacturing facility using a matrix of multi-functional cleanrooms can be adapted to efficiently meet the capacity challenges of both supplying clinical trials and launching products.
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| VIEWPOINT: REGULATIONS |

Pharma Collaboration Proposes Retirement of Obsolete Heavy Metals Tests

Elisabeth Corbett, Andrew Teasdale, Shoreh Shabrang, Lina Wong, Nancy Lewen

The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.
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| EUROPEAN REGULATORY WATCH |

Disputes Over SPC Waivers

Sean Milmo

The European Commission's proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
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| ASK THE EXPERT |

Checking Incoming Goods

Siegfried Schmitt

Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
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