Pharmaceutical Technology-04-02-2008

Pharmaceutical Technology

Inside IPEC-EUROPE: Pharmaceutical Excipients—The View from the EU

April 02, 2008

Inside IPEC

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A changing regulatory environment is on the horizon for excipient suppliers and users.

Report From: China

April 02, 2008

News

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Although there have been recent setbacks for China with regard to exported products, the country has made substantial strides in its pharmaceutical industry over the past few years. Intense competition and a series of new regulations seem to be moving the country into a period of recovery.

Tracking the Potential of Excipients

April 02, 2008

Online Exclusive

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Excipient producers and industry observers share their perspectives on innovation for excipients.

Coming Down the Pike: Bispecific mABs

April 02, 2008

News

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Antibodies are highly specific molecules that can be tailored to recognize almost any stretch of peptide that nature can conjure: a feature that has been exploited for years now to produce therapeutic antibodies.

Equipment Hold-Time for Cleaning Validation

April 02, 2008

Peer-Reviewed Research

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Regulatory agencies expect companies to establish and monitor clean equipment- and dirty equipment-hold times for manufacturing equipment as part of their cleaning validation program.

In the Spotlight April 2008

April 02, 2008

In the Spotlight

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Manufacturers expect to see the latest developments in process equipment at INTERPHEX, and this year's show was no disappointment. Exhibitors regularly display additions to their lines of encapsulators, tablet presses, material-handling machines, and other automated manufacturing equipment. But the products on view in Philadelphia Mar. 26–28 were not limited to manufacturing applications.

Running a Marathon in Flip-Flops – Part 1: The Value of Incorporating Prerequisites into Process Validation

April 02, 2008

Online Exclusive

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Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.

Journey to the Center of the Lung

April 02, 2008

Online Exclusive

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What makes a drug ripe for respiratory delivery?