Development

Articles

The authors discuss a continuous-flow reactor that avoids parallel channels and enables economic plant setup. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

Microstructured Reactors for Rapid Process Development and Scale-Up

The authors discuss the capabilities of immobilization technologies and the ability to use an expanded range of solvents for mobile-phase components and solvent dissolutions. This article is part of a special issue on APIs.

Method Development for Analysis and Isolation of Chiral Compounds Using Immobilized Stationary-Phase Technology

The authors describe several examples of using asymmetric hydrogenation and biocatalysis for synthesizing several secondary alcohol compounds.

Asymmetric Routes to Chiral Secondary Alcohols

CPhI Worldwide 2010 Booth Invitations

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

Week of Aug. 16, 2010: Company and People Notes: Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

Making highly potent active pharmaceutical ingredients (HPAPIs) can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.

Are Disposable Components Powerful Enough to Manufacture Highly Potent Drugs?

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Sen. Michael Bennet (D-CO) introduced a bill earlier this month, the Drug Safety and Accountability Act of 2010, which is designed to improve regulatory oversight of drug-manufacturing facilities and improve related quality standards and monitoring.

Senate Introduces New Bill on Drug-Manufacturing Quality Standards

Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

Week of Aug. 9, 2010: Company and People Notes: Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.

Ingredients