Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.

Tracking Innovation in New Molecular Entities of 2013

Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.

Applying Catalysis to Optimize API Synthesis

With the enforcement of the European Directive 2011/62/EU relating to medicinal products for human use regarding falsified medicinal products, new requirements are introduced for active substances. The new regulation requires among other things, documentation of the supply chain traceability.

New rule on importing Active Pharmaceutical Ingredients (API) to the EU countries.

Cedarburg Hauser Pharmaceuticals has upgraded its API plant in Wisconsin.

Cedarburg Hauser Upgrades API Manufacturing Plant

Pfizer advances its pipeline of antibody-based therapies using a host cell line that combines engineered glycosylation technology and enhanced gene-expression.

Pfizer Applies Integrated Technology for Cell-Line Development of Proprietary Antibodies

New partnership aims to eliminate months from the typical transition time required to move chemistry from the laboratory into commercial applications.

Sigma-Aldrich, The Scripps Research Institute Translating Research into Commercial Applications

Developments involve stereoretentive cross-coupling, enantioselective alcohol silylation, strategies for amplifying signals in circular dichroism spectroscopy, and a synthetic route for the natural product ingenol.

Advancing Chiral Chemistry in Pharmaceutical Synthesis

Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.

Gaining Insights on Contract Chemical API Manufacturing An Industry Roundtable

Commercial-scale amide formation and an improved process route for a tetracycline derivative are some recent developments in API synthesis.

Advancing API Synthesis

A recent FDA guidance places greater attention on cocrystals as a tool in solid-dosage formulation.