Drug Development

The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.

An Industry Roundtable Moderated by Patricia Van Arnum and Rich Whitworh. Contract service and technology providers share their perspectives on the influence of quality by design in the expectations between sponsor companies and outsourcing providers.

Avantor reviews its experience with the Rx-360 shared audit pilot program, which is aimed at protecting the pharmaceutical supply chain. This article is part of a special issue on Outsourcing.

Even though manufacturers are responsible for ensuring the quality of combination products, some companies may not be certain about what quality system to apply to their production.

The same recipe obtained in laboratory-scale equipment cannot, without modifications, generally be used to freeze-dry the product in a pilot-scale or industrial-scale freeze-dryer.

The performance of biotechnology venture capital and investment is lackluster at best.

A new report places pharmaceutical and healthcare companies ahead in corporate and social governance.

The solid form of an API plays a crucial role in drug quality, and advancing methods for screening, detection, and characterization is key.

Member states in the EU are working to implement the newly passed Falsified Medicines Directive.

High demand could lead to innovation in controlled-release injectables.

Better strategies and practices in sourcing and procurement can contribute to the bottom line.

Pharmaceutical manufacturers look to various solutions to resolve the challenge of poorly soluble drugs

The authors investigate the influence of hydro-alcoholic media on hydration and drug release from polyethylene oxide extended-release matrices.

The current review describes the role and selection of excipients, pellet core, coating materials, and compression with various cushioning agents.

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.