Manufacturing

The Fluid Air Tablet Coating System consists of a modular air atomizing manifold, liquid-delivery skid, and Batch Architect process controls.

The Solidlab laboratory plant combines powder mixing, granulating, and coating of pharmaceutical pellets and tablets in one single machine.

The Silverson Ultramix can provide high-shear mixing in vessels with narrow openings.

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

Applying model-predictive methods and a continuous process-control framework to a continuous tablet-manufacturing process.

The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies.

Researchers at the Scripps Research Institute advance heteorcylic chemistry trhough new reagents and reaction-tracking techniques.

A recent study of computer-created and natural proteins suggests the number of sites where small-molecule drugs can bind to proteins is limited, thereby narrowing how to mitigate side effects through drug design.

Models and modeling software gain a foothold in solid-dosage manufacturing process design.

Crushing, fracturing, and bending tests quantify hardness.

Approvals of new drugs are on an upward swing, but only a few CMOs are benefiting.

Microwave spectroscopy overcomes some of the limitations of circular dichroism and vibrational circular dichroism in analyzing enantiomers.

An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.

GSK expands its vaccines platform technology expertise by acquiring Okairos, a Swiss-based company.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

Adoption of single-use systems and more flexible systems drive innovation.

Greater automation and the adoption of solid versus perforated pans are some recent advances.

The growing demand for targeted biopharmaceutical therapies is driving interest in modular production facilities that can be rapidly constructed while still minimizing risk and cost.

Dynamic testing and advances in shear testing provide better insight into powder physical properties and external variables that affect powder behavior.

Integrated serialization systems keep pace with industry demand.

Crushing, fracturing, and bending tests quantify hardness.

Making the effort to apply new methods to pharmaceutical processing will bring benefits.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

Drug manufacturers today are increasingly challenged to find new, effective methods for the delivery of active pharmaceutical ingredients, and many are discovering that orally disintegrating technologies can help.

New platform technologies and polymer chemistries may facilitate self-administration, longer-term delivery, and targeted delivery of parenteral drugs.

Pfizer has launched a prescription-fulfillment website for Viagra tablets in an effort to combat the online sale of counterfeited medicine.

Podcast interview with Nick Johnson, Strategic Marketing Director for Modified Release Technologies at Catalent Pharma Solutions

Applications of ZFN technology in biopharmaceutical cell-line engineering.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

The rejection by India's Supreme Court on Novartis' Glivec/Gleevec (imatinib mesylate) and other recent case law raise important issues on patent strategies for solid forms.