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

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September 2018
Volume 42, 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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PharmTech September Issue

Thought-Leadership Video Series: The Use of Extractables Data from Single-Use Components for Risk Assessments
Sade Mokuolu of Watson Marlow Fluid Technology Group talks with Pharmaceutical Technology about extractables studies on different types of single-use components.Watch Now

| 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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| 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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| 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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| FROM THE EDITOR |

Be a Part of the Solution

Rita C. Peters

Sharing know-how can help resolve common bio/pharma technical challenges.
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| US REGULATORY WATCH |

FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies

Jill Wechsler

More consistent and reliable production processes are critical for advancing innovative treatments.
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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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