Manufacturing

pharmaceutical science and technology innovations

IPEC-Americas has just completed a major update to its significant change guideline to address current issues in the manufacture of excipient ingredients and to assist manufacturers in developing an impurity profile.

This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.

The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study.

New fixed-dose combination drugs aim to enhance safety and efficacy, while regulators clear a path for more drug–device combination products.

The author reviews dimensional analysis as a straight-forward approach to scale up.

The author describes strategies for analytical method development that are helpful in achieving quality by design and efficiency.

The author points out some major obstacles to effective scale-up and describes methods available to pharmaceutical scientists for addressing scalability issues.

In the manufacture of many pharmaceutical products, dry-particle blending is a critical step that directly affects content uniformity.

Novartis to Expand Generics Hold

CBER Draft Guidance for Spore-Formers and Plasmid Vaccines

GlaxoSmithKline Rebrands AIDS Drugs

Interphex

Lilly Implements Bar Coding on Individual Insulin Vials

NIH Prohibits Employees from Collaborating with Pharmaceutical Companies

Barcode PDF

SAFE Electronic Identity Standard for Drug Industry

Extrusion-spheronization and pellet compression are effective means of developing first-order kinetic, controlled-release drug delivery systems of azithromycin (AZI). The authors prepared, evaluated, and optimized AZI formulations and assessed the stability of the selected formulation under accelerated storage conditions.

The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.

Pharmaceutical Science & Technology Innovations

Analytical instrument suppliers are developing manufacturing-tailored tools that are small, precise, and easy to use.

European Directive 2004/27/EC will have massive repercussions on the manufacture and marketing of APIs and some excipients across Europe...

A look at how process analytical technology promises to be the most radical change in pharmaceutical manufacturing in 30 years...

FDA cites Essential Pharmacy Compounding (Omaha) for bulk-compounding of verterinary drugs.

Laser-Marking Technique Improves Tablet Branding