Pharmaceutical Technology-09-02-2018

Pharmaceutical Technology

Taste-Blocking—An Alternative to Tastemasking

September 02, 2018

Features

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Senomyx uses an approach, known as taste-blocking, to address the challenges of bitter APIs. Kenneth J. Simone, vice-president of Pharmaceutical Business Development, Senomyx, speaks with Pharmaceutical Technology about this technology.

Disputes Over SPC Waivers

September 02, 2018

Regulatory Watch

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The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.

Isolator and Filling Machine for Vials

September 02, 2018

Product Spotlight

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groninger and SKAN have collaborated to develop Integra, a production line concept that integrates both an isolator and filling machine for vials with a large capacity range.

Be a Part of the Solution

September 02, 2018

From the Editor

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Sharing know-how can help resolve common bio/pharma technical challenges.

Clinical Manufacturing: Clearing Higher Hurdles

September 02, 2018

Features

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Increasingly complex trial protocols have added to IMP manufacturing challenges.

Focusing on the Last Link

September 02, 2018

Cover Story

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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?

Rethinking Cleaning Validation for API Manufacturing

September 02, 2018

Peer-Reviewed Research

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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.

Checking Incoming Goods

September 02, 2018

Ask the Expert

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

Biopharma Demand Continues to Influence CMO Actions

September 02, 2018

Outsourcing Outlook

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Partnerships, mergers, and new services indicate that biologics are continuing to influence CMOs’ and CDMOs’ decisions to expand their biopharmaceutical services.

Pharmaceutical Technology North America, September 2018 (PDF)

September 02, 2018

Issue PDF

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Click the title above to open the Pharmaceutical Technology September 2018 issue in an interactive PDF format.

FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies

August 02, 2018

Regulatory Watch

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