Manufacturing

Aptuit To Purchase Quintiles

Able Labs Files for Chapter 11

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Xanodyne Acquires aaiPharma Assets

Chiron Cuts Supply of Flu Vaccines Made in Germany; Liverpool Plant Under Inspection

Able Interim Chief Resigns Amid Drug Recall

First Contraceptive Spray Offers Advantages over the Pill

Q Chip Develops Fully Functioning MicroPlant

A stepwise, process risk-assessment approach can facilitate the identification and understanding of critical process parameters, quality attributes, and in-process controls. This approach can lead to more use of science- and risk-based regulatory practices to simplify the regulatory requirements for changes to synthetic processes and to support the underlying quality systems that ensure compliance.

Singapore is competing aggressively with India and China for a piece of the Asian sourcing business.

Can macromolecular processes learn from small-molecule experience? Burdened by exploding bioreactor productivity, architects of downstream bioseparation technology are looking into the drug industry's past for inspiration, while small-molecule companies adopt techniques pioneered by biotechnology. (The first of three articles on the current state of separations.)

Genentech Anticipates Full-Capacity Manufacturing

Schering AG To Cut Plants and Staff

Molding Technique Improves Nanoparticle Production

Warning Letter: Pragmatic Materials

FDA Posts Q5E Biotech and Biological Products Comparability Guideline

Blister Packaging Trumps Bottles For Patient Compliance, Study Shows

Wyeth and Purdue Announce Restructuring Plans

Development Collaboration for Ophthalmic Drugs Could Eliminate Injections

Warning letter: C&M Oxyfill

Self-Assembly Nanotechnology Improves Microencapsulation

Eli Lilly Scales Back Planned Virginia Insulin Plant

Officials at the US Food and Drug Administration are working with industry and academia to develop more efficient and reliable drug production processes that can ensure a consistent supply of high-quality therapies. A modern manufacturing system based on harmonized regulatory policies across global regions is critical for meeting public demand for safe and effective medicines, while also reducing production costs and eliminating waste.

Once considered mainly an afterthought in a company's lifecycle-management strategy, controlled-release dosage forms are now positioned at the forefront of many formulation strategies. In contrast to drug discovery, formulation work focuses not only on the intricacies of the active pharmaceutical ingredient (API), but also on fine-tuning the excipients, the release profile, and the delivery mechanism to provide optimal therapeutic benefit. Because of their wide range of applications and functionalities, especially in controlled-release therapies, polymers are among the most widely used excipients.