Manufacturing

The limited effectiveness of some existing drugs and demand for new therapeutic candidated for complex diseases has spurred the development of the biopharmaceutical market...

This article describes the approach to maintenance management that delivers enhanced compliance for direct impact GMP systems...

Shortages of Key Drugs

"Stable Liquid" Technology Permits Heptavalent Vaccine Against Botulism

Novel Microbial Expression System Yields Dowpharma-Pfizer Agreement

Nanoparticle Synthesis Process Facilitates Chiral Separations

UK MHRA Okays Chiron Flu Vaccine Plant; FDA Approval Still to Come

FDA Approves Treatment for Smallpox Vaccination Side Effects

Nanoparticle Synthesis Process Facilitates Chiral Separations

Big Pharma Companies Team Up to Develop Once-Daily, Triple-Combination HIV Drug

Pharmaceutical packaging can no longer be an afterthought in pharmaceutical product development.

Some published articles purport to demonstrate the difficulties and problems of the laser diffraction technique without mentioning that these apparent problems are inherent in all particle-sizing techniques. This article discusses some of the advantages of using laser diffraction for particle sizing-including repeatability, ease of verification, and speed of measurement-and why it has become the preferred technique in a range of industries.

After a five-year downturn, cautious optimism is taking hold among API manufacturers.

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