Volume 28, Number 5

Table of Contents

Articles

Functional Safety in the Life Science Industries

by David Hatch, Iwan van Beurden, Eric W. Scharpf, Iwan van Beurden, David Hatch, Eric W. Scharpf
This article presents an overview of functional safety within the life science industry based on international standards.

Innovations in Process Technology for Manufacture of APIs and BPCs

by John Nichols, John Nichols
This article discusses the future of API Manufacturing and the role ISPE can play in driving industry innovation.

ISPE Baseline® Pharmaceutical Engineering Guide for New and Renovated Facilities Volume 2: Oral Solid Dosage Forms (Revision) – Executive Summary

This executive summary provides an overview of the second edition of the ISPE Baseline® Guide: Oral Solid Dosage Forms. The revision of the Guide was prompted by a number of developments within the industry requiring the guidance to be realigned and refreshed.

Industry Interview Series: Norman Winskill, Vice President, Global Technology, Pfizer Global Manufacturing and Kelvin Cooper, Senior Vice President, Pfizer Worldwide Pharmaceutical Sciences

In this interview, Norman Winskill and Kelvin Cooper discuss how Pfizer manages the important interface between development and manufacturing. They also give insight into Pfizer’s strategic thinking on QbD, lean approaches, outsourcing, new manufacturing technologies, and green chemistry.

How to Make a Perforated Pan PAT-Compliant

by Davide Manca, Caterina Funaro, Fiorenzo Cembali, Giusi Mondelli, Giorgio Tarozzi, PierAntonio Ragazzini, Fiorenzo Cembali, David Manca, Caterina Funaro, Giusi Mondelli, Giorgio Tarozzi, Pierantonio Ragazzini
This article describes a PAT-approach to the coating process performed in a perforated pan. The main topics include process understanding, Quality by Design, and process regulation and control.

Doxorubicin Loaded Contrast Agents for Ultrasound Triggered Drug Delivery: Importance of Process Parameters

by John Eisenbrey, Phyllis Huang, Michael Soulen, Margaret Wheatley, Mr. John Eisenbrey, Phyllis Huang, Michael Soulen, Ms. Margaret Wheatley
This article discusses research contributing to the development of a drug delivery platform that has the potential to greatly reduce systemic toxicity commonly associated with chemotherapy, while increasing the concentration of the drug at a tumor site. First presented by John Eisenbrey at the 2007 ISPE Delaware Valley Student Poster Competition, this research went on to win the Graduate Level award at the ISPE International Student Poster Competition in Las Vegas, NV later that year.

Departments

ISPE Update

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Global Regulatory News

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