Drug Development

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

A perspective from Pfizer on the lessons from small-molecule manufacturing that can be applied to biomanufacturing.

The author examines sample-preparations methods used in inductively coupled plasma–optimal emission spectroscopy for four test metals.

Last week, Ben Venue Laboratories decided to exit the contract-manufacturing business during the next several years, thus ending more than 70 years of service in this field. To ensure the supply of medically necessary products, the company will work with its customers to develop and execute long-term transition plans.

The authors present a method for controlling the release of therapeutics by applying a plasma polymer layer to the surface of porous materials.

O-arylation and O-alkylation, a one-pot protein synthesis, a combined approach in continued and chemocatalysis, and green-chemistry applications are the target of some recent advances in API synthesis.

China rises to the top as a destination for international outsourcing.

New studies reveal the promise and feasibility of transdermal vaccine delivery.

Quality management requires more effort in a complex supply chain.

A path to personalized medicines creates a new paradigm for development and manufacturing.

Pfizer's Experience with QbD. This article is part of a special issue on Outsourcing.

The article examines the drivers of customer perception of contract service providers of pharmaceutical development and manufacturing.

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.