Manufacturing

Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and performance. The author examines common shortcomings in change control when implementing non-enterprise solutions and the functionality derived from enterprise-level change control.

Also, Covance and WuXi PharmaTech to form contract research joint venture in China, Covidien makes appointments to its Pharmaceutical Products and Imaging Solutions businesses, more...

Richard E. Maleczka Jr. and Milton R. Smith III, professors of the Department of Chemistry at Michigan State University, were recognized by the Environmental Protection Agency's Presidential Green Chemistry Challenge Awards, for designing a catalytic reaction to synthesize precursors for the Suzuki-coupling reaction.

Molecular Profiles created a poster that demonstrates the efficacy of its "nanoPASS" (nanoscale predictive analytical screening solution) technique to characterize an active pharmaceutical ingredient's (API) surface energy.

President Bush signed H.R. 2642, the Supplemental Appropriations Act of 2008, which provides $150 million to the US Food and Drug Administration for medical-safety and drug-safety activities.

Drugmakers seeking to block the activity of a protein may have a new strategy at their disposal.

Staff reductions are not surprising with the state of the economy and falling pharmaceutical sales.

This review article explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug.

A new book explains process analytical technology, drug stability, and quality.

The authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions.

The year 2011 may seem far off, but there is much to do to prepare for electronic pedigrees.

A growing preference for public-private partnerships is spurring innovation and technology among Dutch pharmaceutical companies.

Natale S. Ricciardi, president of Pfizer Global Manufacturing and senior vice-president of Pfizer, discusses the company's new manufacturing focus that features plant network optimization, increased outsourcing, and greater adoption of agile or lean manufacturing.

They may have seemed harmless at first, but these ideas took a big bite.

Forums, blogs, and more can spark innovation.

Polyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules.

With no economic relief in sight, industry, like all of us, is grappling with high-and new-costs.

New scientific discoveries promise to expand treatments for rare and neglected diseases.

Patient safety must be the primary concern of any validation effort. The author explains how a risk-based approach to validation and compliance follows naturally from this premise.

Recent reports discuss the future of pharma's emerging markets.

Editors' Picks of Pharmaceutical Science & Technology Innovations

The year 2007 was slow for approvals for new molecular entities and overall pharmaceutical industry growth. Big Pharma seeks relief in a growing biologics portfolio.

The pharmaceutical majors invest in biologics production capacity as they advance restructuring programs and build their pipelines

Last year, the Royal Pharmaceutical Society of Great Britain held a consultation regarding how the profession should develop during the next 12 years. An analysis of the results has just been published.1 It comes as no surprise to anyone who teaches pharmaceutics at UK pharmacy departments that one popular suggestion was to change the indicative syllabus so that it would focus more on clinical topics as opposed to scientific ones.

At first glance, the title of this article may bring a wry smile to the face of many an astute practitioner, but I can provide 'documentary evidence' that free validation is not a just a play on words, but a financial reality.