Drug Development

Two popular methods for detecting protein aggregates are analytical ultracentrifugation (AUC) and size-exclusion chromatography?multiangle light scattering (SEC?MALS). These techniques? results correlate relatively well, but each one has its own strengths.

Listen to roundtables from the 2011 ExcipientFest/IPEC conference, addressing developing issues in excipient functionality and continuous manufacturing.

Can microdosing make medicines safer and more effective for children?

More sophisticated biological expression systems expand the functionality of the traditional systems for protein synthesis.

A recent industry survey shows keen interest in improving bioreactors and cell-culture media.

The study results suggested that Pluronic F127 might be a potent inhibitor of drug precipitation for Labrasol formulations.

Sometimes, there are just too many cooks in the kitchen.

Effective containment in API and drug-product manufacturing encompasses a variety of process, equipment, and operational issues.

BASF's Jan Bebber explains why immediate-release formulations boost drug efficacy and aid patient compliance.

The rising popularity of fast dissolving, immediate-release dosage forms can be attributed to their convenience and ease of administration.

Teva Pharmaceutical Industries agreed to pay shareholders $460 million in cash to acquire a 57% stake in Taiyo Pharmaceutical Industry. Teva also will offer to buy all outstanding shares of Taiyo.

The Office of the United States Trade Representative issued a report as part of its annual review of the global state of intellectual-property rights protection and enforcement.

PhRMA Urges Congress to Reauthorize Legislation for Pediatric Drugs.

The IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients.

Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.

The authors examine the influence of glass-transition temperature, melt viscosity, degradation temperature, and process settings.

Emerging methods could provide alternative ways of producing inhalable drug particles.

Approaches in using small-molecule and peptide synthesis offer promise in widening the scope of drug candidates.

Nanosponges, a controlled-release nanoparticle system, shows promise in targeted drug delivery

Can the semiconductor industry help Big Pharma develop therapies?

Many factors affect research results.

The authors provide further insight into microRNA biology, and the simplicity of anti-miR oligonucleotide drug delivery.

The author describes recent developments to help overcome the downstream processing bottleneck. This article is part of a special issue on Sterile Manufacturing and Bioprocessing.

Linking peptides to polyethylene glycol, or PEGylation, has helped improve pharmaceutical therapeutics in several ways. A wave of new techniques is now ushering in further advances.

GlaxoSmithKline (GSK) identified certain over-the-counter (OTC) brands in its consumer healthcare business that the company plans to divest.

Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

On Tuesday, Apr. 19, 2011, officials from FDA, the US Department of Health and Human Services, and the Drug Enforcement Administration introduced President Obama?s plan for curbing prescription-drug diversion and abuse.

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

An uncertain regulatory environment affects funding for biotechnology.

Chemocatalytic and biocatalytic routes play an important role in improving the manufacture of intermediates and active pharmaceutical ingredients.